Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer (2001)
Chapter: Index
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Appendix: Workshop speakers and other contributors
defined, 244
Ataxia telangiectasia, 44-45, 237
Benign tumors
biopsies, 2, 52, 53
unnecessary, 29, 55, 84, 90, 132, 134
breast self-examination, 29
magnetic resonance imaging (MRI), 78-79
mammographic findings, 2, 36, 55
scintimammography, 61
ultrasound, 78, 79
Bias, 157, 158, 162, 180
see also Randomization
defined, 26 (n.2), 237, 242
lead-time, 26, 27, 186, 242
length bias, 26, 27, 186, 201, 242
selection bias, 28-29, 181, 182
Biofield Breast Examination, 64, 93-95
Bioinformatics, 5, 11, 131, 141, 233
defined, 238
Biomarkers, 5-7, 11, 17, 29, 105-132, 222, 225-227
see also Cellular processes; Fluids, breast; Genetic factors; Molecular biology; Proteins
defined, 238, 244, 247
funding for research, 20, 21, 23, 24, 132, 233
metastasis, 29, 104, 117-118, 122, 123, 125
positron emission tomography and, 88
recurrent cancers, 125, 142
Biomedical Information Science and Technology Implementation Consortium, 141
Biopsies, 29, 52, 129, 211, 212, 225
banks, 5, 11-12, 106-107, 130-131, 233-234, 246
benign tumors, 2, 52, 53; see also “unnecessary” infra
biology of breast cancer, general, 106
Breast Imaging Reporting and Data System (BIRADS), 37
breast self-examination and, 29
computer-aided detection, 75
core-needle biopsies, 37-38, 129, 195, 239
defined, 238, 246
digital mammography and, 72
elastic scattering spectroscopy (ESS) and, 90
false positive mammographs and, 2, 53
FDA adoption criteria, 156
fine-needle aspiration biopsies, 37, 84, 129, 195, 211, 240
gene expression studies, 121
magnetic resonance imaging (MRI) and, 81, 84
magnetic resonance spectroscopy (MRS), 5, 56, 57, 60-61, 84-85, 243
“optical,” 89, 91
pain and reduced sexual sensitivity, 39
procedures described, 37-38
unnecessary, 29, 55, 84, 90, 132, 134
vacuum-assisted, 38
Biostatistics, FDA approval process, 12, 154, 234
Biotechnology, 125, 126, 141
private sector, 17, 149
Blue Cross/Blue Shield Association (BCBSA), 86, 176-177, 188
BRCA,
see Breast cancer-associated tumor suppressor gene
Breast and Cervical Cancer Mortality Prevention Act, 211
Breast and Cervical Treatment Act, 14, 236
Breast cancer-associated tumor suppressor gene (BRCA), 6, 44, 45-46, 108, 110-114, 224, 227, 238
Breast Cancer Fund, 23
Breast Cancer Progress Review Group, 130
Breast Cancer Research Foundation, 23
Breast Cancer Research Program, 142-143, 144-145
Breast Cancer Surveillance Consortium, 13, 14, 191-192, 229-230, 235, 236
Breast-conserving therapy
digital mammography, FDA approval, 160
magnetic resonance imaging (MRI), 81
Breast fluids, see Fluids, breast
Breast Imaging Reporting and Data System, 36, 37
Calcium and calcification, 37, 38, 57, 59
defined, 244
magnetic resonance imaging (MRI), 81-82
ultrasound, 77
Canada, 35, 52, 113-114, 187-188
Cancer Genome Anatomy Project (CGAP), 106-107, 131, 136
Capillary optic arrays, 71
Carcinoembryonic antigens, 123, 127-128, 181
cDNA, 2, 6, 108, 119, 120, 121, 122, 238
Cell cultures, 5, 109, 124-126
Cellular processes, general
see also Biopsies; Fluids, breast; Genetic factors
definitions, 239
epithelial cells, 93, 121, 123, 125, 128, 240
funding for research, 20, 24, 132, 138
growth in young women, 44
magnetic resonance imaging, 83
Center for Devices and Radiological Health, 149, 153
Center for Health Plans and Providers, 172
Center for Practice and Technology Assessment, 174
Centers for Disease Control and Prevention (CDC)
screening program, 14, 220, 230, 236
uninsured women, screening of, 10, 230, 236
Central Intelligence Agency (CIA), 134, 135
Cervical cancer, see Pap smears
Chemotherapy
cell cultures, 125
scintimammography, 87
China, 29
Civil Health and Medical Program of the Uniformed Services, 172
Clinical breast examinations, 1, 8, 33, 50(n.11), 80-81, 180, 203
see also Clinical practice guidelines;
Imaging technologies, general;
specific techniques
Agency for Healthcare Research and Quality (AHRQ), 13, 235
defined, 238
interval cancers, 38, 44, 72, 184
Clinical Laboratory Improvement Amendments, 113, 169
Clinical outcome, 5, 8-9, 12, 13, 15, 19, 26, 27, 136, 165, 184, 234, 235
see also Clinical trials; Life expectancy; Mortality; Sensitivity; Specificity
defined, 238
FDA approval process, 154, 165
Clinical practice guidelines, 11, 52, 178, 179, 180, 202-203, 209-210, 219, 222
FDA guidelines, 151
magnetic resonance imaging (MRI), 82
Pro*Duct catheter, 161
risk-based, 217-219
Clinical trials, 1, 3, 9, 12-13, 33, 57, 74, 75, 135-136, 178-181, 189(n.11), 222
see also Clinical outcome
ataxia telangiectasia, 45
breast self-examination, 29
Cancer Genome Anatomy Project, 107
cost of, 9, 12, 146, 159, 235
defined, 238-239
digital mammography, 3, 70-71, 72, 136, 158, 159
electrical potential measurements, 94
electronic palpation, 97
FDA criteria/approval process, 12, 13, 151, 153, 154, 155, 161, 164, 166, 171, 234, 235
funding, 12, 13, 20, 21, 22, 23, 136, 138, 142, 177
genetic testing, 112-113, 114
life expectancy, 26, 27, 40
magnetic resonance imaging (MRI), 5, 61, 82, 83, 84, 218, 225
mortality measures, 14, 19, 26, 34, 43, 154, 222-223, 228, 235
NCI sponsorship, 13, 14, 181, 190-192, 200, 229-230, 234, 235, 236
nipple aspiration fluid, 127
prevention trials, 54(n.12)
Pro*Duct catheter, 161
randomization, 1, 2, 15, 26, 33, 179, 180-181, 184, 190-191, 197, 200, 217, 222-223, 228-229
defined, 245
metastasis, 49
screening mamammography, 34, 35, 42, 43, 49, 222-223
scintimammography, 86
standards, general, 19, 26, 151, 178, 181-184
thermography, 92
ultrasound, 5, 225
various imaging technologies, 58-66 (passim), 135-136
women over 70 years of age, 2, 14, 40-41, 52, 201
World Health Organization guidelines, 19, 26
Cloning, 125, 239, 245
Computer-aided detection or diagnosis, 34, 17, 57, 58-59, 68, 74-76, 134, 224, 228
see also Digital mammography; High-throughput technology
bioinformatics, 5, 11, 131, 141, 233, 238
defined, 239
electrical impedance, 96
FDA approval, 4, 75, 163, 224
funding, 21, 56, 134
Internet, 135(n.1)
microwave imaging, 100
NCI initiatives, 56, 134
optical imaging, 90
thermography, 92-93
tomography (CT), 4, 57, 73, 86, 150, 195, 224, 239, 244-245
virtual reality, 97, 102, 247
workstations and displays, 21, 56, 68-69
Computer applications, other, 12, 17
see also Databases; Internet
bioinformatics, 5, 11, 131, 141, 233, 238
cost-effectiveness analysis models, 187, 224-225
high-throughput technology, 5, 11, 105, 110, 118, 119, 122, 124, 130, 131, 141, 227, 233, 241
pattern recognition, 56
RNA changes, 108, 121
telemammography, 71, 246
texture analysis, 56
virtual reality, 97, 102, 247
workstations and displays, 21, 56, 68-69
Confidentiality, see Privacy and confidentiality
Consent, see Informed consent
Contrast agents, 59, 60, 61, 78, 81-82, 83, 91, 103, 161
defined, 239, 241-242
Cooperative Trials in Diagnostic Imaging, 21
Core-needle biopsies, 37-38, 129, 195, 239
Cost and cost-effectiveness factors, 133-134, 167, 185-188, 189, 190, 191, 196, 199, 218, 220, 230, 235
see also Funding; Health insurance
Advanced Technology Program, 144, 145
Agency for Healthcare Research and Quality, 174
clinical trials, 9, 12, 146, 159, 235
computer-aided detection, 74
computer models of, 187, 224-225
core-needle biopsies, 187
defined, 239
digital mammography, 59, 69, 159, 160, 186-187, 225
elderly women, 40-41
FDA approval, 10, 159, 160, 164
fine-needle aspiration, 187
genetic testing, 114
Hall effect imaging, 101
Health Care Financing Administration, 172, 194, 230
historical perspectives, 167
magnetic resonance imaging (MRI), 44, 82, 86, 101, 187
Medicare/Medicaid reimbursement and, 13-14, 170, 172
mammography, 10, 14, 36, 40-41, 103, 186, 193-194, 211-213, 219, 227, 231, 235-236
new technologies, general, 10, 17, 19, 146, 149, 185-188, 227, 231
venture capital, 146-148, 149, 164
optical imaging, 90
positron emission tomography, 88
quality-adjusted life years (QALYs), 185, 186
scintimammography, 86
screening, general, 10, 12, 13-14, 28-29, 182
specimen banks, 11, 130, 132, 233-234
ultrasound, 44, 82, 86, 101, 187
Counseling, 113, 206
Court cases, see Malpractice
Cysts, 37
ultrasound, 76-77, 78, 79
Databases, 12, 13
see also Bioinformatics; Internet; Specimen banks
bioinformatics, 5, 11, 131, 141, 233, 238
Cancer Genome Anatomy Project, 106-107
clinical trials, 138
NCI efforts, 141, 191-192
standards, 107, 192
DCIS, see Ductal carcinoma in situ
Defense Appropriations Act, 143
Demographic factors
see also Age factors; Educational attainment; Race/ethnicity; Socioeconomic status
access to health care, 206, 207, 208
computer-aided detection, 75
databases, 192
geographic, 181
immigrants, 208
Department of Commerce, see National Institute of Standards and Technology
Department of Defense, 17, 139, 142-143, 144-145, 228
Army Breast Cancer Research and Materiel Command, 70
Army Medical Research and Materiel Command, 142-143
Civil Health and Medical Program of the Uniformed Services, 172
digital mammography, 70, 72
Federal Multi-Agency Consortium to Improve Women's Health, 135
Department of Energy, 135
Department of Health and Human Services, 14, 17, 113, 169, 208
see also Agency for Healthcare Research and Quality; Centers for Disease Control and Prevention; Food and Drug Administration; Health Care Financing Administration; National Cancer Institute; National Institutes of Health
Department of Veterans Affairs, 172
Dense tissue, see Tissue density
Development and Testing of Digital Mammography Displays and Workstations, 21
Diaphanography, see Transillumination
Digital mammography (FFDM), 3, 17, 57, 58-59, 67-71, 224, 225, 228, 230
clinical trials, 3, 70-71, 72, 136, 158, 159
computer-aided, 17, 74, 75
defined, 239, 240
electronic palpation, 97
FDA approval, 4, 59, 70, 75, 134, 156-161, 164, 165, 224
funding for research, 23, 134
NCI initiatives, 134
telemammography, 71, 246
thermography, 92-93
tissue density, 68-69, 136
Director's Challenge: Toward a Molecular Classification of Tumors, 21
Disabled persons, 19, 182, 205-206, 216-217
Discomfort, see Pain and discomfort
Discrimination, genetic, 11, 112, 129-130, 227, 233
Displays, see Workstations and displays
DNA, 105, 107, 108, 110, 111, 117, 118-119, 240, 245
see also Genomics
arrays, 6, 110, 118, 119-120, 121, 124, 127, 131, 146, 244
cDNA, 2, 6, 108, 119, 120, 121, 122, 238
defined, 239, 244
methylation, 6, 119, 243
polymerase chain reaction, 6, 108, 118, 119, 122, 131, 245
Doppler effect, 4, 57, 59, 78
Ductal carcinoma in situ (DCIS), 46-48, 51-52, 121, 125, 183, 226, 240
Dynamic area telethermometry, 93
Early Clinical Advanced Technology Program, 21
Early Detection Research Network, 20
Economic factors, 8, 147, 167, 219, 228
see also Cost and cost-effectiveness factors; Funding; Socioeconomic status
Education, see Patient education and outreach; Professional education
Educational attainment, 206, 207, 208
Effectiveness, 1, 5, 17, 19, 26, 52, 131, 178, 184
see also Cost and cost-effectiveness factors; Sensitivity; Specificity
age factors, 40-41, 44
Agency for Healthcare Research and Quality, 175
computer-aided detection, 163
defined, 178, 240
diagnostic delays, 40
early detection, 48, 50
FDA approval process, 12, 13, 34, 65, 113, 151-155 (passim), 157, 160, 163, 168, 170, 171
magnetic resonance imaging (MRI), 83, 84-85
magnetomammography, 101
microwave imaging, 100
National Cancer Institute (NCI), 13, 190-192, 235
NIH Office of Medical Applications of Research, 175
older women, 40-41
private insurers, 177
scintimammography, 87
specimen banks, 130
Efficacy, 26, 154, 178, 182, 218
see also Sensitivity; Specificity chemotherapy, 87
clinical trials, 155
counseling regarding, 113
defined, 178, 240
FDA approval process, 13, 17-18, 155, 157, 159, 189
National Cancer Institute, 13, 235
older women, 40
scintimammography, 102
Elastic scattering spectroscopy, 89-90
Elastography, 4, 57, 78-79, 240
Elderly persons, 220, 223, 230, 231, 236
see also Medicare
clinical data on mammography, 2, 14, 40-41, 52, 201
clinical practice guidelines, 210
Medicare, 13-14, 169-174, 190, 193-195, 199, 210, 215, 232, 235-236, 243
patient education and outreach, 202, 203, 204, 205-206, 208-209
risk assessment, 113, 231
state screening mandates, 175
Electrical impedance tomography system, 64-65, 95-96
defined, 240
FDA approval, 4, 57, 65, 224
TransScan electrical impedance imaging, 64, 96, 161-162
Electrical potential measurements, 57, 62-63, 93-95, 240
Electronic palpation, 33, 57, 64-65, 96-98
defined, 240
FDA approval, 4, 57, 63, 94, 97, 98
Emotional factors, see Psychological/emotional factors
Ensuring Quality Cancer Care, 206
Epidemiology, 106, 107
see also Incidence and prevalence;
Mortality
Cancer Genome Anatomy Project, 107
defined, 240
FDA criteria, 12, 234
Epigenetic factors, 6, 117, 118-119, 131, 240
Epithelial cells, 93, 121, 123, 125, 128, 240
Estrogen, 43, 122, 128, 218
Etiology, 5, 11, 106, 131, 191, 225, 233
see also Biomarkers; Cellular processes, general; Genetic factors; Molecular biology
European Economic Area, 94-95
Evidence-based practice centers (EPCs), 174, 175, 177
Family factors, 105, 107, 110, 112, 113, 114, 192, 218, 224, 240
psychosocial factors, 112
False negatives, 2, 40, 50, 53, 71, 75, 112, 156, 163, 183-184, 223, 240
False positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
Federal Food, Drug, and Cosmetic Act, 151(n.18), 167-168
Federal government, 11
see also Funding; Legislation; Regulatory issues; specific departments and agencies
coordination of research, 24, 135, 143, 165, 191
Federal Multi-Agency Consortium to Improve Women's Health, 135
Film-screen mammography (FSM), 57, 69, 71, 72, 74, 104, 186, 225, 231, 240
defined, 246
FDA approval, 4, 57, 152-153, 157, 159, 160-161, 165, 198
Fine-needle aspiration biopsies, 37, 84, 129, 187, 195, 211, 240
Fluids, breast, 5, 37, 77, 105, 107, 126-128, 132, 161
cysts, 37, 76-77, 78, 79
fine-needle aspiration biopsies, 37, 84, 129, 195, 211, 240
lavage, 7, 127, 156, 161
nipple aspiration, 7, 126-127, 244
Fluorescent in situ hybridization, 6, 108, 117-118, 120, 240
approval criteria/process, 6-7, 12, 17, 113, 134, 149, 151-156, 164, 165-166, 167-168, 170-172, 196-197, 198, 227, 228, 234-235
biostatistics, 12, 154, 234
case studies of approval, 156-163
clinical outcomes, 154, 165
clinical trials, 12, 13, 151, 153, 154, 155, 161, 164, 166, 171, 234, 235
effectiveness, 12, 13, 34, 65, 113, 151-155 (passim), 157, 160, 163, 168, 170, 171
efficacy, 13, 17-18, 155, 157, 159, 189
epidemiology, 12, 234
historical perspectives, 156-163, 164-165, 167-168
investigational device exemptions (IDEs), 151, 166, 170, 171
premarket approval, 94, 96, 97, 151, 152, 157, 159, 160, 163, 164, 171
sensitivity/specificity, 154, 161, 162, 165, 234
approval stage, various technologies, 6-7, 58-65, 156-163, 224; see also specific technologies infra
Center for Devices and Radiological Health, 149, 153
clinical practice guidelines, 151
cost-effectiveness analysis, 188
digital mammography, 4, 59, 70, 75, 134, 156-161, 164, 165, 224
electronic impedance, 4, 57, 65, 224
Federal Multi-Agency Consortium to Improve Women's Health, 135
funding for research coordination, 24
investigational device exemptions (IDEs), 151, 166, 170, 171
magnetic resonance imaging (MRI), 4, 5, 79, 159, 224
magnetic resonance spectroscopy, 4, 57
Medicare coverage/reimbursement, 170
premarket approval, 94, 96, 97, 151, 152, 157, 159, 160, 163, 164, 171
premarket notification, 151, 153
mammography facility inspections, 34, 36
optical spectroscopy, 4, 57, 89, 91
pad to assist self-examination, 33
scintimammography, 4, 57, 61, 85, 87, 224
thermoacoustic computed tomography, 4, 57, 224
thermography, 4, 63, 92, 93, 150
ultrasound, 4, 224
Food and Drug Administration Modernization Act, 152
Foreign countries, see International perspectives;
specific countries
Friends...You Can Count On, 24
Full-field digital mammography, see Digital mammography
Functional magnetic resonance imaging, 83
Funding, 133, 137-146, 163-164, 211, 228
see also Cost and cost-effectiveness factors
biomarkers, general, 20, 21, 23, 24, 132, 233
cellular biology research, general, 20, 24, 132, 138
clinical trials, 12, 13, 20, 21, 22, 23, 136, 138, 142, 177
computer-aided detection, 21, 56, 134
Department of Defense, 142-143, 144-145
digital mammography, 23, 134
genetic testing/treatment, 23, 116, 142, 146, 233
imaging, general, 21-22, 136, 141, 146, 148-149, 165, 230
professional education, 14, 236
research, general, 17, 20-24, 135, 233
specimen banks, 11-12, 130, 131, 233-234
technology development process, general, 8, 11
venture capital, 146-147, 149, 164
World Health Organization, 177
Gadolinium agents, 83
Gamma camera, 61, 87, 101, 102, 241
Gel electrophoresis, 7, 124, 241
General Accounting Office
Genetic factors, 6, 11, 17, 105-124, 142, 192, 227
see also Biomarkers; DNA; Family factors; Mutation; Race/ethnicity; RNA
bioinformatics, 131
breast cancer-associated tumor suppressor gene (BRCA), 6, 44, 45-46, 108, 110-114, 224, 227, 238
cloning, 125, 239, 245
definitions, 237, 238, 241
discrimination, 11, 112, 129-130, 227, 233
epigenetic factors, 6, 117, 118-119, 131, 240
fluorescent in situ hybridization, 6, 108, 117-118, 120, 240
funding for research, 23, 116, 142, 146, 233
health insurers, 113-114
discrimination, 11, 112, 129-130, 227, 233
HER-2 gene amplification, 51
magnetic resonance imaging, 83
oligonucleotides, 110, 142, 244
p53 tumor suppressor genes, 114, 128, 227
polymorphisms, 6, 108, 118, 128, 245
transcription, 108, 110, 119, 121, 122, 246, 247
tumor suppressor gene, 114, 117, 119, 247
Genomics, 118, 119, 181, 239, 241
Comparative Genomic Hybridization, 6
fluorescent in situ hybridization, 118
National Human Genome Research Institute
Geographic factors, 181
Government role, see Federal government; Legislation; Regulatory issues; State government; specific departments and agencies
Hall effect imaging, 57, 64-65, 100-101
Handicapped persons, see Disabled persons
Health Care Financing Administration (HCFA), 12, 13-14, 169-174, 189(n.11), 196, 197, 234, 235
see also Medicaid; Medicare
cost-effectiveness analysis, 188
effectiveness of procedures, 170, 171, 173
funding for research, 24
National Center for Health Care Technology and, 169
Health insurance, 10, 14, 136, 153, 176-177, 204-205, 210
see also Medicaid; Medicare
Blue Cross/Blue Shield Association (BCBSA), 86, 176-177, 188
Centers for Disease Control and Prevention (CDC), screening of uninsured, 10, 230, 236
coverage, 8, 10, 12, 13, 17, 18, 53, 135, 165, 166, 168, 169-177 (passim), 188, 189, 190, 192-193, 196, 199, 234
genetic testing, 113-114
discrimination, 11, 112, 129-130, 227, 233
reimbursement decisions, 5, 10, 13, 53, 135, 168, 169-173 (passim), 177, 192-196, 199, 211-212, 215(n.5), 219, 222, 227, 231, 232, 235-236
state mandates, 175, 232
technology development/assessment process, 8, 12, 13, 17, 18, 153, 165, 166, 176-177, 227, 234, 235
Health Insurance Plan of Greater New York, 33, 153
Health Insurance Portability Act, 112
Health Resources and Services Administration, 14, 236
Healthy People 2010, 14, 208, 236
HER-2 gene amplification, 51
Heterozygosity
ataxia telangiectasia, 45
defined, 241
loss of, 117, 118, 243
High-throughput technology, 5, 11, 105, 110, 118, 119, 122, 124, 130, 131, 141, 227, 233
defined, 241
Historic perspectives, 15-17, 18, 51, 167-168, 197, 223-224, 228
cost of health care, 167
Department of Defense funding, 142-143, 144-145
digital mammography, 156-161
FDA approval process, 156-163, 164-165, 167-168
imaging products, shipments, 150
magnetic resonance imaging (MRI), 79-80
mammography, introduction/diffusion of, 10, 15-17, 200-204, 217, 219
NCI funding, 137, 138-139, 140
nipple aspiration, 126
proteome, 124
Hodgkin's lymphoma, 44, 121
HRGI, see National Human Genome Research Institute
Human mammary epithelial cells, see Epithelial cells
Japan, 113-114
Kaiser Permanente, 177
Keratins, 123, 128
Magnetic resonance imaging (MRI), 17, 56, 57, 60-61, 79-84, 91, 134, 150, 195, 224-225
see also Contrast agents
biopsies and, 38
clinical trials, 5, 61, 82, 83, 84, 218, 225
defined, 243
elastography, 78-79, 82
FDA approval, 4, 5, 79, 159, 224
functional, 93
Internet, 135(n.1)
recurrent cancers, 60, 82
sensitivity, 81, 82, 91
specificity, 78-79, 81, 91
standards, 82, 219
Magnetic resonance spectroscopy (MRS), 56, 57, 60-61, 84-85
defined, 243
FDA approval, 4, 57
NCI initiatives, 61, 82
Magnetomammography, 57, 64-65, 101-102
Males, see Men
Malpractice, 40, 193, 215-217, 220
Mammography, 29, 33-53, 56, 102-103, 136, 143, 150, 158, 181, 192, 193, 195, 202-223, 225, 229-232
see also Contrast agents; Digital mammography; Film-screen mammography; Patient education and outreach
adoption and dissemination, 9
age factors, 2, 14
benign tumors, 2, 36, 55
computer-aided detection and, 163
cost of, 10, 14, 36, 40-41, 103, 186, 193-194, 211-213, 219, 227, 231, 235-236
defined, 239, 243, 246
disabled persons, 19, 182, 205-206, 216-217
electrical impedance and, 96
electronic palpation and, 97
expenditures on, 149
false negatives, 2, 40, 50, 53, 71, 75, 156, 163, 183-184, 223, 240
false positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
film-screen mammography
full-field digital mammography
historical perspectives, 10, 15-17, 200-204, 217, 219
Internet, 135(n.1)
lesion classification, 2
magnetic resonance imaging (MRI) and, 61, 80-81, 82
magnetomammography, 57, 64-65, 101-102
Medicare coverage, 170
mortality rates and, 38, 43. 49-51, 52, 55, 103
nipple aspiration fluid and, 127
Pro*Duct catheter and, 161
racial/ethnic factors in use of, 206, 207, 208
sensitivity, general, 9, 12, 25, 53, 55, 136, 219
socioeconomic status, 206, 207, 208
specificity, general, 9, 12, 25, 38-39, 53, 136
standards, general, 14, 34-37 (passim), 102-103, 193-194, 206, 218-219, 222, 236
state health insurance mandates, 175, 232
telemammography, 71, 246
thermoacoustic computed tomography and, 98, 99
tissue density, 2, 37, 43, 55, 68-69, 136, 223
TransScan electrical impedance imaging and, 64, 96, 161-162
Mammography Quality Standards Act (MQSA), 14, 34-35, 193-194, 222, 236
Mammotome, see Vacuum-assisted biopsies
Managed care, 8, 176-177
Mastectomy, 5, 44, 112, 245
The Mathematics and Physics of Emerging Biomedical Imaging, 56
Medicaid, 10, 13-14, 167, 169, 211, 230, 235-236
defined, 243
Medical Coverage Advisory Committees (MCACs), 172, 173
Medical Device Amendment, 92, 151, 153, 156-157, 158
Medical Technology Leadership Forum, 189
Medicare, 13-14, 169-174, 190, 193-195, 199, 210, 215(n.5), 232, 235-236
defined, 243
Men
breast cancer incidence, 218(n.6)
prostate cancer, 175, 180-181, 232
Menstrual cycle, 43, 128-129, 218
definitions, 243
electrical impedance, 162
menopause, 43, 127, 129, 218, 243
Meta-analysis, 34, 82, 174, 177-178, 179, 209
defined, 243
Metastasis, 19, 29, 34, 38, 40, 41, 46, 49, 50-54 (passim), 61, 104, 117-118, 122, 123, 125, 137, 142, 209, 225, 226
defined, 243
magnetic resonance imaging (MRI), 82
Methylation, 6, 119, 243
MIBI see Scintimammography; Technetium-99m sestamibi
Microwave imaging, 23, 56, 57, 64-65, 99-100
Mitochondrial DNA, 127
Molecular biology, 11, 105-106, 137, 226-227, 244
see also Biomarkers; Genetic factors; Immunohistochemistry; Proteins
carcinoembryonic antigens, 123, 127-128, 181
funding for research, 20, 21, 137, 142
Mortality, 1-2, 5, 9, 13, 18, 51, 103, 131, 151, 204, 210, 223, 229
see also Life expectancy
breast self-examination and, 29(n.4)
clinical trials, 14, 19, 26, 34, 43, 154, 222-223, 228, 235
defined, 244
disease-specific, 181, 184, 190, 235
genetic testing, 112, 226
international perspectives, 52, 223
mammography and, 38, 43. 49-51, 52, 55, 103
metastasis, 49
mRNA, 119, 121-122, 243
M1000 ImageChecker, 163
Multidisciplinary approaches, 134, 137, 138-139, 177
coordination of federal research, 24, 135, 143, 165, 191
Unconventional Innovations Program, 29, 139, 141, 142
Mutation, 6, 105, 107-124, 127, 227, 241
ataxia telangiectasia, 45
breast cancer-associated tumor suppressor gene (BRCA), 6, 44, 45-46, 108, 110-114, 224, 227, 238
defined, 244, 246
inherited, 44
p53 tumor suppressor genes, 114, 128, 227
Observational studies, 34, 179-180, 244
Occult tumors, see Asymptomatic (occult) tumors
Office of Bioengineering, Bioimaging, and Bioinformatics, 141
Office of Medical Applications of Research, 175
Office of Technology and Industrial Relations, 137, 138-139
Office of Technology Assessment, 169
Office on Women's Health (OWH), 134, 135
Oligonucleotides, 110, 142, 244
Optical imaging, 56, 57, 62-63, 88-91
defined, 244
biopsies, 89, 91
electronic palpation, 97
FDA approval, 4, 57, 89, 91
Optical spectroscopy, 57, 62-63, 89
Optical tomography, 62-63, 90
OTIR, 20
Outreach, see Patient education and outreach
Overtreatment/overdiagnosis, 2, 5, 28, 29, 46-48, 55, 132, 204
biopsies, unnecessary, 29, 55, 84, 90, 132, 134
breast self-examination, 29
defined, 244
Pacific Center for Ethics and Applied Biology, 19
Pain and discomfort, 10, 12, 231
see also Psychological/emotional factors
biopsies, 39
optical imaging, 90
Palpation, 27, 53, 64, 78, 97-98, 157, 223
see also Self-examination
electronic, 4, 33, 57, 63, 64-65, 94, 96-98, 240
scintimammography and, 86
Patents, see Intellectual property
Patient education and outreach, 9-10, 199-213, 219-220
counseling, 113, 206
elderly persons, 202, 203, 204, 205-206, 208-209
genetic testing, 112-113
informed consent, 11, 13, 113, 129-130
Pattern recognition, 56, 102, 134
Peptides, 125
p53 tumor suppressor genes, 114, 128, 227
Pharmaceuticals, 229
chemotherapy, 87, 125
contrast agents, 59, 60, 61, 78, 81-82, 83, 91, 103, 161, 239, 241-242
estrogen replacement, 43, 122, 128
expenditures on, 148-149
radiopharmaceuticals, 21, 85-86, 88; see also “contrast agents” supra
scintimammography, multidrug resistance, 87
Phase-contrast X-ray imaging, 71, 73
Phased Innovation Award, 20, 21
Phased Technology Application Award, 21
Physicians, 209, 210, 230
age of patients, 208-209
FDA approved techniques, 165
histological diagnosis, 49
malpractice, 40, 193, 215-217, 220
Medicare reimbursement, 193
technology adoption, 165, 167, 188-189
World Health Organization clinical trial guidelines, 19, 26
PMA, see Premarketing approval
Polymerase chain reaction (PCR), 6, 108, 118, 119, 122, 131
defined, 245
Polymorphisms, 6, 108, 118, 128
defined, 245
Positive predictive value, 25, 40, 55, 75, 245
false negatives, 2, 40, 50, 53, 71, 75, 112, 156, 163, 183-184, 223, 240
false positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
Positron emission tomography, 4, 56, 57, 62-63, 88, 135(n.1)
defined, 245
Poverty, see Socioeconomic status
Pregnancy, scintimammography, 86
Premarketing approval (PMA), 94, 96, 97, 151, 152, 157, 159, 160, 163, 164, 171
Premarket notification, 151, 153
Prevalence, see Incidence and prevalence
Preventive Services Task Force, 29(n.3), 173-174, 209
Privacy and confidentiality, 11, 112, 129-130, 227, 233
Private sector, 8, 17, 116, 133-134, 146-149, 163-164, 172, 176-177, 189, 228
see also Health insurance; Intellectual property; Regulatory issues
Advanced Technology Program, 143-146
biotechnology, 17, 149
foundation programs, funding, 23-24
specimen banks, 130-131
venture capital, 146-148, 149, 164
Pro*Duct catheter, 161
Professional education, 9-10, 190, 199, 211, 213-215, 220, 236
see also Specimen banks
funding, 14, 236
Prognosis, 104
see also Life expectancy
databases, 191, 192
defined, 245
DNA arrays, 121
fluorescent in situ hybridization, 118
magnetic resonance imaging (MRI), 82-83
thermography, 91
Prostate cancer, 175, 180-181, 232
Proteins, 5, 7, 11, 109, 114, 117, 119, 122-124, 226, 233, 245
serum, 105, 122, 127, 128-129, 132
Proton magnetic resonance spectroscopy,
see Magnetic resonance spectroscopy
Psychological/emotional factors
see also Pain and discomfort
biopsies, general, 156
BRCA mutations, 112
false positives, 39, 183
PTEN, see Tumor suppressor gene
Public education,
see Patient education and outreach
Public Health Service
see also Agency for Healthcare Research and Quality
Preventive Services Task Force, 29(n.3), 173-174, 209
Quality-adjusted life years (QALYs), 185, 186
Quality control
see also Regulatory issues; Standards
Agency for Healthcare Research and Quality, 174
evidence, 180
mammogram interpretation, 2, 5
NCI programs, 191
Quality of life, other, 185-186
see also Pain and discomfort; Psychological/emotional factors
Race/ethnicity
databases, 192
mammography use, 206, 207, 208
Radiation doses, 55, 156, 201
reduction in, 17, 224
scintimammography, 86
Radiation sensitivity, 9, 12, 15, 44-46
Radiation therapy, 51-52, 150
Radioactive antibodies, 62-63
Randomization
clinical trials, 1, 2, 15, 26, 33, 179, 180-181, 184, 190-191, 197, 200, 217, 222-223, 228-229
screening mammography, 34, 35, 42, 43, 49, 222-223
defined, 245
observational studies, 180
Recurrent breast cancer
biomarkers, 125, 142
ductal carcinoma in situ, 51-52
magnetic resonance imaging (MRI), 60, 82
Regulatory issues, 8-9, 10, 53, 133, 135, 151, 164, 222, 225, 227
see also Food and Drug Administration; Legislation; Standards
electrical potential measurements, Europe, 94-95
labeling, 152, 161, 165
Reverse transcription, 108, 119, 246
Riboflavin carrier protein, 128
Risk assessment, 28, 49, 54, 107, 217-219, 226, 227, 232
see also Age factors; Family factors; Race/ethnicity
biomarkers, 132
clinical practice guidelines, 217-219
cost-effectiveness, 28-29
definitions, 28, 237, 245, 246
elderly persons, 113, 231
FDA approval and, 151
germ-line mutations, 107-116
radiation sensitivity, 44-46
scintimammography, 86
thermography, 91
Risk reduction, 5
RNA, 108, 119, 121-122, 244
mRNA, 119, 121-122, 243
Russia, 29
Scintimammography, 56, 57, 60-61, 85-87, 101-102
defined, 246
FDA approval, 4, 57, 61, 85, 87, 224
sensitivity, 86, 101-102
specificity, 85, 86
Self-examination (BSE), 33-34
defined, 238
education and outreach, 200
intervals, 1, 29, 202, 203, 204
pad to assist, FDA approved, 33
Sensitivity, 182, 183-184, 197, 229, 231, 242
biomarkers, 109
cost of technology and, 168
digital mammography, 70, 136, 230
electrical impedance measurements, 162
electrical potential measurements, 94
false negatives, 2, 40, 50, 53, 71, 75, 112, 156, 163, 183-184, 223, 240
false positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
FDA approval process, 154, 161, 162, 165, 234
magnetic resonance imaging (MRI), 81, 82, 91
magnetomammography, 101-102
mammography, general, 9, 12, 25, 53, 55, 103, 136, 219
optical imaging, 88, 91
Pro*Duct catheter, 161
scintimammography, 86, 101-102
ultrasound, 82
Sexual sensitivity, biopsies, 39
Single-photon emission computed tomography, 86, 244-245
Small Business Innovative Research, 137
Small Business Technology Transfer Research, 137
SNP Consortium Ltd., 116
Social Security Act, 170
Society of Breast Imaging, 14, 212, 213
Socioeconomic status, 182, 206, 207, 208
Medicaid, 10, 13-14, 167, 169, 211, 230, 235
Specificity, 9, 12, 25, 38-39, 53, 103, 136, 219, 229, 230
biomarkers, 109
computer-aided detection, 74
defined, 246
electrical impedance measurements, 162
electrical potential measurements, 94
false positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
FDA approval process, 154, 161, 162, 165, 234
magnetic resonance imaging (MRI), 78-79, 81, 91
mammography, general, 9, 12, 25, 38-39, 53, 136
optical imaging, 88, 91
positron emission tomography, 88
Pro*Duct catheter, 161
scintimammography, 85, 86
ultrasound, 77, 78-79
Specimen banks, 5, 11-12, 13, 106-107, 130-131
defined, 246
funding, 11, 130, 131, 132, 233-234
Spectroscopy, 7, 142, 182, 183-184, 197, 231
see also Elastic scattering spectroscopy; Electrical impedance tomography system; Magnetic resonance spectroscopy; Optical spectroscopy
Standards, 33, 178-184, 190, 197
see also Clinical practice guidelines; Cost and cost-effectiveness factors; Effectiveness; Efficacy; Food and Drug Administration; Regulatory issues; Sensitivity; Specificity
biomarkers, 107, 130
clinical trials, general, 19, 26, 151, 178, 181-184
data, 107, 192
electronic palpation, 97
genetic information, use of, 112, 227, 233
ideal screening tool, 232-233
magnetic resonance imaging (MRI), 82, 219
mammography, general, 14, 34-37(passim), 102-103, 193-194, 206, 218-219, 222, 236
Medicare coverage, 172-173
National Institute of Standards and Technology, 143-146
periodic health examinations, 182
pharmaceuticals, 229
specimen banks, 130
state health insurance mandates, 175
tissue density classification, 218-219
World Health Organization clinical trial guidelines, 19, 26
State Children's Insurance Program, 169
State government
health insurance coverage, 175, 232
Medicaid, 10
Steroids, 125
Superconducting quantum interference device (SQUID), magnetomammography, 57, 64-65, 101-102
Surgery
see also Biopsies
breast-conserving therapy, 81, 161
breast self-examination and, 29
ductal carcinoma in situ (DCIS), 51-52
elastic scattering spectroscopy (ESS) and, 90
lumpectomies, 82, 83
mastectomy, 5, 44, 112, 245
Medicare coverage, 173
Susan G. Komen Breast Cancer Foundation, 23
Technetium-99m sestamibi (MIBI), 61, 87, 102
see also Scintimammography
Telemammography, 71, 246
Texture analysis, 56
FDA approval, 4, 57, 224
Thermography, 57, 91-93
defined, 247
FDA approval, 4, 63, 92, 93, 150
infrared thermography, 62-63, 91-93
Thermotherapy, 83, 247
Three-dimensional interactive visualization, 66-67, 102
Internet, 135(n.1)
Tissue density, 2, 37, 43, 55, 136, 223
classification standards, 218-219
digital mammography, 68-69, 136
microwave imaging, 100
nipple aspiration fluid, 127
scintimammography, 86
ultrasound, 77
Tissue specimen banks, see Specimen banks
Tomography
computer-aided, 4, 57, 73, 86, 150, 195, 224, 239, 244-245
defined, 247
electrical impedance tomography system, 95-96
funding for research, 23
optical tomography, 62-63, 90
positron emission tomography, 4, 56, 57, 62-63, 88, 135(n.1), 245
single-photon emission computed tomography, 86, 244-245
thermoacoustic computed tomography, 4, 57, 64-65, 98-99. 224
tuned aperture computed tomography, 73
Transcription, 108, 110, 119, 121, 122, 246, 247
Transillumination, 88-89
TransScan electrical impedance imaging, 64, 96, 161-162
Trials of Imaging Agents, 21
Tumor markers, see Biomarkers
Tumor Marker Utility Grading System, 124
Tumor suppressor gene, 114, 117, 119, 247
Tuned aperture computed tomography (TACT), 73
Ultrasound, 5, 17, 38, 39, 56, 57, 58-59, 76-79, 134, 150, 195, 211, 225
cost of, 44, 82, 86, 101, 187
defined, 247
elastography, 4, 57, 78-79, 240
expenditures on, 149
FDA approval, 4, 224
Hall effect imaging, 57, 64-65, 100-101
Internet, 135(n.1)
magnetic resonance imaging (MRI) and, 82
sensitivity, 82
specificity, 77, 78-79
thermoacoustic computed tomography, 4, 57, 64-65, 98-99, 224
Unconventional Innovations Program, 29, 139, 141, 142
United Kingdom, 188
magnetic resonance imaging (MRI), 82
Vacuum-assisted biopsies, 38
Venture capital, 146-148, 149, 164
Virtual reality, 97, 102, 247
Whitaker Foundation, 23
Workshop on Sensors for Bio-Molecular Signatures, 24
Workstations and displays, 21, 56, 68-69
World Health Organization, 177
clinical trial guidelines, 19, 26
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 273
Index
A
Access to care,
10,
14,
208,
211-212,
219-220,
230
see also Health insurance
disabled persons, 19, 182, 205-206, 216-217
race/ethnicity, 206, 207, 208
socioeconomic status, 182, 206, 207, 208
Accuracy, see Positive predictive value; Sensitivity; Specificity
Advanced Breast Biopsy Instrumentation, 38
Advanced Medical Technology Association, 173(n.4)
Advanced Technology Program, 143-146
Advocacy groups, 11, 13, 113, 133, 143, 163, 172, 228, 233, 235
Age factors, 2, 103, 218, 224
clinical practice guidelines, 210
databases, 192
effectiveness, 40-41, 44
magnetic resonance imaging (MRI), 82
mammography, patient acceptance/use, 206, 207, 230
scintimammography, 86
screening, general, 35, 40-44, 52, 103, 201, 202-203
screening, women over 40 years of age, 14, 34, 35, 42, 52, 70, 175, 201, 202, 203, 204, 208-209, 210, 220, 223, 230, 236;
see also Elderly persons
ultrasound, 77
Agency for Healthcare Research and Quality, 172, 174-175, 189(n.11)
clinical trials, 13, 235
Preventive Services Task Force, 29(n.3), 173-174, 209
Alliance of Genetic Support Groups, 113
American Association for Cancer Research, 54(n.12)
American Board on Radiology, 213
American Cancer Society, 34, 175, 200-201, 202
American College of Radiology, 14, 34, 201, 202, 236
American College of Radiology Imaging Network, 13, 136, 230, 235, 236
American Medical Association, 172, 193, 202
Animal models, 124-125
breast cancer-associated tumor suppressor gene (BRCA), 45
drug development, FDA process, 155
magnetic resonance imaging (MRI), 83
Antigens, see Carcinoembryonic antigens
Applied Research Program, 191
Army Breast Cancer Research and Materiel Command, 70
Army Medical Research and Materiel Command, 142-143
Aspiration, see Fine-needle aspiration biopsies; Nipple aspiration
see also Health insurance
disabled persons, 19, 182, 205-206, 216-217
race/ethnicity, 206, 207, 208
socioeconomic status, 182, 206, 207, 208
Accuracy, see Positive predictive value; Sensitivity; Specificity
Advanced Breast Biopsy Instrumentation, 38
Advanced Medical Technology Association, 173(n.4)
Advanced Technology Program, 143-146
Advocacy groups, 11, 13, 113, 133, 143, 163, 172, 228, 233, 235
Age factors, 2, 103, 218, 224
clinical practice guidelines, 210
databases, 192
effectiveness, 40-41, 44
magnetic resonance imaging (MRI), 82
mammography, patient acceptance/use, 206, 207, 230
scintimammography, 86
screening, general, 35, 40-44, 52, 103, 201, 202-203
screening, women over 40 years of age, 14, 34, 35, 42, 52, 70, 175, 201, 202, 203, 204, 208-209, 210, 220, 223, 230, 236;
see also Elderly persons
ultrasound, 77
Agency for Healthcare Research and Quality, 172, 174-175, 189(n.11)
clinical trials, 13, 235
Preventive Services Task Force, 29(n.3), 173-174, 209
Alliance of Genetic Support Groups, 113
American Association for Cancer Research, 54(n.12)
American Board on Radiology, 213
American Cancer Society, 34, 175, 200-201, 202
American College of Radiology, 14, 34, 201, 202, 236
American College of Radiology Imaging Network, 13, 136, 230, 235, 236
American Medical Association, 172, 193, 202
Animal models, 124-125
breast cancer-associated tumor suppressor gene (BRCA), 45
drug development, FDA process, 155
magnetic resonance imaging (MRI), 83
Antigens, see Carcinoembryonic antigens
Applied Research Program, 191
Army Breast Cancer Research and Materiel Command, 70
Army Medical Research and Materiel Command, 142-143
Aspiration, see Fine-needle aspiration biopsies; Nipple aspiration
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 274
Asymptomatic (occult) tumors, 19, 40, 43, 46, 48, 50, 77, 230defined, 244
Ataxia telangiectasia, 44-45, 237
B
Benign tumors
biopsies, 2, 52, 53
unnecessary, 29, 55, 84, 90, 132, 134
breast self-examination, 29
magnetic resonance imaging (MRI), 78-79
mammographic findings, 2, 36, 55
scintimammography, 61
ultrasound, 78, 79
Bias, 157, 158, 162, 180
see also Randomization
defined, 26 (n.2), 237, 242
lead-time, 26, 27, 186, 242
length bias, 26, 27, 186, 201, 242
selection bias, 28-29, 181, 182
Biofield Breast Examination, 64, 93-95
Bioinformatics, 5, 11, 131, 141, 233
defined, 238
Biomarkers, 5-7, 11, 17, 29, 105-132, 222, 225-227
see also Cellular processes; Fluids, breast; Genetic factors; Molecular biology; Proteins
defined, 238, 244, 247
funding for research, 20, 21, 23, 24, 132, 233
metastasis, 29, 104, 117-118, 122, 123, 125
positron emission tomography and, 88
recurrent cancers, 125, 142
Biomedical Information Science and Technology Implementation Consortium, 141
Biopsies, 29, 52, 129, 211, 212, 225
banks, 5, 11-12, 106-107, 130-131, 233-234, 246
benign tumors, 2, 52, 53; see also “unnecessary” infra
biology of breast cancer, general, 106
Breast Imaging Reporting and Data System (BIRADS), 37
breast self-examination and, 29
computer-aided detection, 75
core-needle biopsies, 37-38, 129, 195, 239
defined, 238, 246
digital mammography and, 72
elastic scattering spectroscopy (ESS) and, 90
false positive mammographs and, 2, 53
FDA adoption criteria, 156
fine-needle aspiration biopsies, 37, 84, 129, 195, 211, 240
gene expression studies, 121
magnetic resonance imaging (MRI) and, 81, 84
magnetic resonance spectroscopy (MRS), 5, 56, 57, 60-61, 84-85, 243
“optical,” 89, 91
pain and reduced sexual sensitivity, 39
procedures described, 37-38
unnecessary, 29, 55, 84, 90, 132, 134
vacuum-assisted, 38
Biostatistics, FDA approval process, 12, 154, 234
Biotechnology, 125, 126, 141
private sector, 17, 149
Blue Cross/Blue Shield Association (BCBSA), 86, 176-177, 188
BRCA,
see Breast cancer-associated tumor suppressor gene
Breast and Cervical Cancer Mortality Prevention Act, 211
Breast and Cervical Treatment Act, 14, 236
Breast cancer-associated tumor suppressor gene (BRCA), 6, 44, 45-46, 108, 110-114, 224, 227, 238
Breast Cancer Fund, 23
Breast Cancer Progress Review Group, 130
Breast Cancer Research Foundation, 23
Breast Cancer Research Program, 142-143, 144-145
Breast Cancer Surveillance Consortium, 13, 14, 191-192, 229-230, 235, 236
Breast-conserving therapy
digital mammography, FDA approval, 160
magnetic resonance imaging (MRI), 81
Breast fluids, see Fluids, breast
Breast Imaging Reporting and Data System, 36, 37
C
Calcium and calcification, 37, 38, 57, 59
defined, 244
magnetic resonance imaging (MRI), 81-82
ultrasound, 77
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 275
California Breast Cancer Research Program, 23Canada, 35, 52, 113-114, 187-188
Cancer Genome Anatomy Project (CGAP), 106-107, 131, 136
Capillary optic arrays, 71
Carcinoembryonic antigens, 123, 127-128, 181
cDNA, 2, 6, 108, 119, 120, 121, 122, 238
Cell cultures, 5, 109, 124-126
Cellular processes, general
see also Biopsies; Fluids, breast; Genetic factors
definitions, 239
epithelial cells, 93, 121, 123, 125, 128, 240
funding for research, 20, 24, 132, 138
growth in young women, 44
magnetic resonance imaging, 83
Center for Devices and Radiological Health, 149, 153
Center for Health Plans and Providers, 172
Center for Practice and Technology Assessment, 174
Centers for Disease Control and Prevention (CDC)
screening program, 14, 220, 230, 236
uninsured women, screening of, 10, 230, 236
Central Intelligence Agency (CIA), 134, 135
Cervical cancer, see Pap smears
Chemotherapy
cell cultures, 125
scintimammography, 87
China, 29
Civil Health and Medical Program of the Uniformed Services, 172
Clinical breast examinations, 1, 8, 33, 50(n.11), 80-81, 180, 203
see also Clinical practice guidelines;
Imaging technologies, general;
specific techniques
Agency for Healthcare Research and Quality (AHRQ), 13, 235
defined, 238
interval cancers, 38, 44, 72, 184
Clinical Laboratory Improvement Amendments, 113, 169
Clinical outcome, 5, 8-9, 12, 13, 15, 19, 26, 27, 136, 165, 184, 234, 235
see also Clinical trials; Life expectancy; Mortality; Sensitivity; Specificity
defined, 238
FDA approval process, 154, 165
Clinical practice guidelines, 11, 52, 178, 179, 180, 202-203, 209-210, 219, 222
FDA guidelines, 151
magnetic resonance imaging (MRI), 82
Pro*Duct catheter, 161
risk-based, 217-219
Clinical trials, 1, 3, 9, 12-13, 33, 57, 74, 75, 135-136, 178-181, 189(n.11), 222
see also Clinical outcome
ataxia telangiectasia, 45
breast self-examination, 29
Cancer Genome Anatomy Project, 107
cost of, 9, 12, 146, 159, 235
defined, 238-239
digital mammography, 3, 70-71, 72, 136, 158, 159
electrical potential measurements, 94
electronic palpation, 97
FDA criteria/approval process, 12, 13, 151, 153, 154, 155, 161, 164, 166, 171, 234, 235
funding, 12, 13, 20, 21, 22, 23, 136, 138, 142, 177
genetic testing, 112-113, 114
life expectancy, 26, 27, 40
magnetic resonance imaging (MRI), 5, 61, 82, 83, 84, 218, 225
mortality measures, 14, 19, 26, 34, 43, 154, 222-223, 228, 235
NCI sponsorship, 13, 14, 181, 190-192, 200, 229-230, 234, 235, 236
nipple aspiration fluid, 127
prevention trials, 54(n.12)
Pro*Duct catheter, 161
randomization, 1, 2, 15, 26, 33, 179, 180-181, 184, 190-191, 197, 200, 217, 222-223, 228-229
defined, 245
metastasis, 49
screening mamammography, 34, 35, 42, 43, 49, 222-223
scintimammography, 86
standards, general, 19, 26, 151, 178, 181-184
thermography, 92
ultrasound, 5, 225
various imaging technologies, 58-66 (passim), 135-136
women over 70 years of age, 2, 14, 40-41, 52, 201
World Health Organization guidelines, 19, 26
Cloning, 125, 239, 245
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 276
Comparative Genomic Hybridization, 6, 108Computer-aided detection or diagnosis, 34, 17, 57, 58-59, 68, 74-76, 134, 224, 228
see also Digital mammography; High-throughput technology
bioinformatics, 5, 11, 131, 141, 233, 238
defined, 239
electrical impedance, 96
FDA approval, 4, 75, 163, 224
funding, 21, 56, 134
Internet, 135(n.1)
microwave imaging, 100
NCI initiatives, 56, 134
optical imaging, 90
thermography, 92-93
tomography (CT), 4, 57, 73, 86, 150, 195, 224, 239, 244-245
virtual reality, 97, 102, 247
workstations and displays, 21, 56, 68-69
Computer applications, other, 12, 17
see also Databases; Internet
bioinformatics, 5, 11, 131, 141, 233, 238
cost-effectiveness analysis models, 187, 224-225
high-throughput technology, 5, 11, 105, 110, 118, 119, 122, 124, 130, 131, 141, 227, 233, 241
pattern recognition, 56
RNA changes, 108, 121
telemammography, 71, 246
texture analysis, 56
virtual reality, 97, 102, 247
workstations and displays, 21, 56, 68-69
Confidentiality, see Privacy and confidentiality
Consent, see Informed consent
Contrast agents, 59, 60, 61, 78, 81-82, 83, 91, 103, 161
defined, 239, 241-242
Cooperative Trials in Diagnostic Imaging, 21
Core-needle biopsies, 37-38, 129, 195, 239
Cost and cost-effectiveness factors, 133-134, 167, 185-188, 189, 190, 191, 196, 199, 218, 220, 230, 235
see also Funding; Health insurance
Advanced Technology Program, 144, 145
Agency for Healthcare Research and Quality, 174
clinical trials, 9, 12, 146, 159, 235
computer-aided detection, 74
computer models of, 187, 224-225
core-needle biopsies, 187
defined, 239
digital mammography, 59, 69, 159, 160, 186-187, 225
elderly women, 40-41
FDA approval, 10, 159, 160, 164
fine-needle aspiration, 187
genetic testing, 114
Hall effect imaging, 101
Health Care Financing Administration, 172, 194, 230
historical perspectives, 167
magnetic resonance imaging (MRI), 44, 82, 86, 101, 187
Medicare/Medicaid reimbursement and, 13-14, 170, 172
mammography, 10, 14, 36, 40-41, 103, 186, 193-194, 211-213, 219, 227, 231, 235-236
new technologies, general, 10, 17, 19, 146, 149, 185-188, 227, 231
venture capital, 146-148, 149, 164
optical imaging, 90
positron emission tomography, 88
quality-adjusted life years (QALYs), 185, 186
scintimammography, 86
screening, general, 10, 12, 13-14, 28-29, 182
specimen banks, 11, 130, 132, 233-234
ultrasound, 44, 82, 86, 101, 187
Counseling, 113, 206
Court cases, see Malpractice
Cysts, 37
ultrasound, 76-77, 78, 79
D
Databases, 12, 13
see also Bioinformatics; Internet; Specimen banks
bioinformatics, 5, 11, 131, 141, 233, 238
Cancer Genome Anatomy Project, 106-107
clinical trials, 138
NCI efforts, 141, 191-192
standards, 107, 192
DCIS, see Ductal carcinoma in situ
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 277
Defense Advanced Research Projects Agency, 139Defense Appropriations Act, 143
Demographic factors
see also Age factors; Educational attainment; Race/ethnicity; Socioeconomic status
access to health care, 206, 207, 208
computer-aided detection, 75
databases, 192
geographic, 181
immigrants, 208
Department of Commerce, see National Institute of Standards and Technology
Department of Defense, 17, 139, 142-143, 144-145, 228
Army Breast Cancer Research and Materiel Command, 70
Army Medical Research and Materiel Command, 142-143
Civil Health and Medical Program of the Uniformed Services, 172
digital mammography, 70, 72
Federal Multi-Agency Consortium to Improve Women's Health, 135
Department of Energy, 135
Department of Health and Human Services, 14, 17, 113, 169, 208
see also Agency for Healthcare Research and Quality; Centers for Disease Control and Prevention; Food and Drug Administration; Health Care Financing Administration; National Cancer Institute; National Institutes of Health
Department of Veterans Affairs, 172
Dense tissue, see Tissue density
Development and Testing of Digital Mammography Displays and Workstations, 21
Diaphanography, see Transillumination
Digital mammography (FFDM), 3, 17, 57, 58-59, 67-71, 224, 225, 228, 230
clinical trials, 3, 70-71, 72, 136, 158, 159
computer-aided, 17, 74, 75
defined, 239, 240
electronic palpation, 97
FDA approval, 4, 59, 70, 75, 134, 156-161, 164, 165, 224
funding for research, 23, 134
NCI initiatives, 134
telemammography, 71, 246
thermography, 92-93
tissue density, 68-69, 136
Director's Challenge: Toward a Molecular Classification of Tumors, 21
Disabled persons, 19, 182, 205-206, 216-217
Discomfort, see Pain and discomfort
Discrimination, genetic, 11, 112, 129-130, 227, 233
Displays, see Workstations and displays
DNA, 105, 107, 108, 110, 111, 117, 118-119, 240, 245
see also Genomics
arrays, 6, 110, 118, 119-120, 121, 124, 127, 131, 146, 244
cDNA, 2, 6, 108, 119, 120, 121, 122, 238
defined, 239, 244
methylation, 6, 119, 243
polymerase chain reaction, 6, 108, 118, 119, 122, 131, 245
Doppler effect, 4, 57, 59, 78
Ductal carcinoma in situ (DCIS), 46-48, 51-52, 121, 125, 183, 226, 240
Dynamic area telethermometry, 93
E
Early Clinical Advanced Technology Program, 21
Early Detection Research Network, 20
Economic factors, 8, 147, 167, 219, 228
see also Cost and cost-effectiveness factors; Funding; Socioeconomic status
Education, see Patient education and outreach; Professional education
Educational attainment, 206, 207, 208
Effectiveness, 1, 5, 17, 19, 26, 52, 131, 178, 184
see also Cost and cost-effectiveness factors; Sensitivity; Specificity
age factors, 40-41, 44
Agency for Healthcare Research and Quality, 175
computer-aided detection, 163
defined, 178, 240
diagnostic delays, 40
early detection, 48, 50
FDA approval process, 12, 13, 34, 65, 113, 151-155 (passim), 157, 160, 163, 168, 170, 171
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 278
Health Care Financing Administration (HFCA), 170, 171, 173magnetic resonance imaging (MRI), 83, 84-85
magnetomammography, 101
microwave imaging, 100
National Cancer Institute (NCI), 13, 190-192, 235
NIH Office of Medical Applications of Research, 175
older women, 40-41
private insurers, 177
scintimammography, 87
specimen banks, 130
Efficacy, 26, 154, 178, 182, 218
see also Sensitivity; Specificity chemotherapy, 87
clinical trials, 155
counseling regarding, 113
defined, 178, 240
FDA approval process, 13, 17-18, 155, 157, 159, 189
National Cancer Institute, 13, 235
older women, 40
scintimammography, 102
Elastic scattering spectroscopy, 89-90
Elastography, 4, 57, 78-79, 240
Elderly persons, 220, 223, 230, 231, 236
see also Medicare
clinical data on mammography, 2, 14, 40-41, 52, 201
clinical practice guidelines, 210
Medicare, 13-14, 169-174, 190, 193-195, 199, 210, 215, 232, 235-236, 243
patient education and outreach, 202, 203, 204, 205-206, 208-209
risk assessment, 113, 231
state screening mandates, 175
Electrical impedance tomography system, 64-65, 95-96
defined, 240
FDA approval, 4, 57, 65, 224
TransScan electrical impedance imaging, 64, 96, 161-162
Electrical potential measurements, 57, 62-63, 93-95, 240
Electronic palpation, 33, 57, 64-65, 96-98
defined, 240
FDA approval, 4, 57, 63, 94, 97, 98
Emotional factors, see Psychological/emotional factors
Ensuring Quality Cancer Care, 206
Epidemiology, 106, 107
see also Incidence and prevalence;
Mortality
Cancer Genome Anatomy Project, 107
defined, 240
FDA criteria, 12, 234
Epigenetic factors, 6, 117, 118-119, 131, 240
Epithelial cells, 93, 121, 123, 125, 128, 240
Estrogen, 43, 122, 128, 218
Etiology, 5, 11, 106, 131, 191, 225, 233
see also Biomarkers; Cellular processes, general; Genetic factors; Molecular biology
European Economic Area, 94-95
Evidence-based practice centers (EPCs), 174, 175, 177
F
Family factors, 105, 107, 110, 112, 113, 114, 192, 218, 224, 240
psychosocial factors, 112
False negatives, 2, 40, 50, 53, 71, 75, 112, 156, 163, 183-184, 223, 240
False positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
Federal Food, Drug, and Cosmetic Act, 151(n.18), 167-168
Federal government, 11
see also Funding; Legislation; Regulatory issues; specific departments and agencies
coordination of research, 24, 135, 143, 165, 191
Federal Multi-Agency Consortium to Improve Women's Health, 135
Film-screen mammography (FSM), 57, 69, 71, 72, 74, 104, 186, 225, 231, 240
defined, 246
FDA approval, 4, 57, 152-153, 157, 159, 160-161, 165, 198
Fine-needle aspiration biopsies, 37, 84, 129, 187, 195, 211, 240
Fluids, breast, 5, 37, 77, 105, 107, 126-128, 132, 161
cysts, 37, 76-77, 78, 79
fine-needle aspiration biopsies, 37, 84, 129, 195, 211, 240
lavage, 7, 127, 156, 161
nipple aspiration, 7, 126-127, 244
Fluorescent in situ hybridization, 6, 108, 117-118, 120, 240
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 279
Food and Drug Administration (FDA), 4, 8, 134, 149-166, 189(n.11)approval criteria/process, 6-7, 12, 17, 113, 134, 149, 151-156, 164, 165-166, 167-168, 170-172, 196-197, 198, 227, 228, 234-235
biostatistics, 12, 154, 234
case studies of approval, 156-163
clinical outcomes, 154, 165
clinical trials, 12, 13, 151, 153, 154, 155, 161, 164, 166, 171, 234, 235
effectiveness, 12, 13, 34, 65, 113, 151-155 (passim), 157, 160, 163, 168, 170, 171
efficacy, 13, 17-18, 155, 157, 159, 189
epidemiology, 12, 234
historical perspectives, 156-163, 164-165, 167-168
investigational device exemptions (IDEs), 151, 166, 170, 171
premarket approval, 94, 96, 97, 151, 152, 157, 159, 160, 163, 164, 171
sensitivity/specificity, 154, 161, 162, 165, 234
approval stage, various technologies, 6-7, 58-65, 156-163, 224; see also specific technologies infra
Center for Devices and Radiological Health, 149, 153
clinical practice guidelines, 151
cost-effectiveness analysis, 188
digital mammography, 4, 59, 70, 75, 134, 156-161, 164, 165, 224
electronic impedance, 4, 57, 65, 224
Federal Multi-Agency Consortium to Improve Women's Health, 135
funding for research coordination, 24
investigational device exemptions (IDEs), 151, 166, 170, 171
magnetic resonance imaging (MRI), 4, 5, 79, 159, 224
magnetic resonance spectroscopy, 4, 57
Medicare coverage/reimbursement, 170
premarket approval, 94, 96, 97, 151, 152, 157, 159, 160, 163, 164, 171
premarket notification, 151, 153
mammography facility inspections, 34, 36
optical spectroscopy, 4, 57, 89, 91
pad to assist self-examination, 33
scintimammography, 4, 57, 61, 85, 87, 224
thermoacoustic computed tomography, 4, 57, 224
thermography, 4, 63, 92, 93, 150
ultrasound, 4, 224
Food and Drug Administration Modernization Act, 152
Foreign countries, see International perspectives;
specific countries
Friends...You Can Count On, 24
Full-field digital mammography, see Digital mammography
Functional magnetic resonance imaging, 83
Funding, 133, 137-146, 163-164, 211, 228
see also Cost and cost-effectiveness factors
biomarkers, general, 20, 21, 23, 24, 132, 233
cellular biology research, general, 20, 24, 132, 138
clinical trials, 12, 13, 20, 21, 22, 23, 136, 138, 142, 177
computer-aided detection, 21, 56, 134
Department of Defense, 142-143, 144-145
digital mammography, 23, 134
genetic testing/treatment, 23, 116, 142, 146, 233
imaging, general, 21-22, 136, 141, 146, 148-149, 165, 230
professional education, 14, 236
research, general, 17, 20-24, 135, 233
specimen banks, 11-12, 130, 131, 233-234
technology development process, general, 8, 11
venture capital, 146-147, 149, 164
World Health Organization, 177
G
Gadolinium agents, 83
Gamma camera, 61, 87, 101, 102, 241
Gel electrophoresis, 7, 124, 241
General Accounting Office
Genetic factors, 6, 11, 17, 105-124, 142, 192, 227
see also Biomarkers; DNA; Family factors; Mutation; Race/ethnicity; RNA
bioinformatics, 131
breast cancer-associated tumor suppressor gene (BRCA), 6, 44, 45-46, 108, 110-114, 224, 227, 238
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 280
clinical trials of genetic testing, 112-113, 114cloning, 125, 239, 245
definitions, 237, 238, 241
discrimination, 11, 112, 129-130, 227, 233
epigenetic factors, 6, 117, 118-119, 131, 240
fluorescent in situ hybridization, 6, 108, 117-118, 120, 240
funding for research, 23, 116, 142, 146, 233
health insurers, 113-114
discrimination, 11, 112, 129-130, 227, 233
HER-2 gene amplification, 51
magnetic resonance imaging, 83
oligonucleotides, 110, 142, 244
p53 tumor suppressor genes, 114, 128, 227
polymorphisms, 6, 108, 118, 128, 245
transcription, 108, 110, 119, 121, 122, 246, 247
tumor suppressor gene, 114, 117, 119, 247
Genomics, 118, 119, 181, 239, 241
Comparative Genomic Hybridization, 6
fluorescent in situ hybridization, 118
National Human Genome Research Institute
Geographic factors, 181
Government role, see Federal government; Legislation; Regulatory issues; State government; specific departments and agencies
H
Hall effect imaging, 57, 64-65, 100-101
Handicapped persons, see Disabled persons
Health Care Financing Administration (HCFA), 12, 13-14, 169-174, 189(n.11), 196, 197, 234, 235
see also Medicaid; Medicare
cost-effectiveness analysis, 188
effectiveness of procedures, 170, 171, 173
funding for research, 24
National Center for Health Care Technology and, 169
Health insurance, 10, 14, 136, 153, 176-177, 204-205, 210
see also Medicaid; Medicare
Blue Cross/Blue Shield Association (BCBSA), 86, 176-177, 188
Centers for Disease Control and Prevention (CDC), screening of uninsured, 10, 230, 236
coverage, 8, 10, 12, 13, 17, 18, 53, 135, 165, 166, 168, 169-177 (passim), 188, 189, 190, 192-193, 196, 199, 234
genetic testing, 113-114
discrimination, 11, 112, 129-130, 227, 233
reimbursement decisions, 5, 10, 13, 53, 135, 168, 169-173 (passim), 177, 192-196, 199, 211-212, 215(n.5), 219, 222, 227, 231, 232, 235-236
state mandates, 175, 232
technology development/assessment process, 8, 12, 13, 17, 18, 153, 165, 166, 176-177, 227, 234, 235
Health Insurance Plan of Greater New York, 33, 153
Health Insurance Portability Act, 112
Health Resources and Services Administration, 14, 236
Healthy People 2010, 14, 208, 236
HER-2 gene amplification, 51
Heterozygosity
ataxia telangiectasia, 45
defined, 241
loss of, 117, 118, 243
High-throughput technology, 5, 11, 105, 110, 118, 119, 122, 124, 130, 131, 141, 227, 233
defined, 241
Historic perspectives, 15-17, 18, 51, 167-168, 197, 223-224, 228
cost of health care, 167
Department of Defense funding, 142-143, 144-145
digital mammography, 156-161
FDA approval process, 156-163, 164-165, 167-168
imaging products, shipments, 150
magnetic resonance imaging (MRI), 79-80
mammography, introduction/diffusion of, 10, 15-17, 200-204, 217, 219
NCI funding, 137, 138-139, 140
nipple aspiration, 126
proteome, 124
Hodgkin's lymphoma, 44, 121
HRGI, see National Human Genome Research Institute
Human mammary epithelial cells, see Epithelial cells
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 281
I
Imaging technologies, general,
1-5,
55-104,
135-136,
146,
221-222,
223-224,
227-230,
231-232
see also Computer-aided detection or diagnosis; Contrast agents; Hall effect imaging; Magnetic resonance imaging; Magnetic resonance spectroscopy; Mammography; Microwave imaging; Optical imaging; Scintimammography; Thermography; Tomography
disabled persons, 19, 182, 205-206, 216-217
expenditures on, 149
funding, general, 21-22, 136, 141, 146, 148-149, 165, 230
infrared thermography, 62-63, 91-93
magnetomammography, 57, 64-65, 101-102
Medicare coverage, 173
National Electrical Manufacturers' Association, 135, 150
virtual reality, 97, 102, 247
Immigrants, 208
Immunohistochemistry, 7, 45, 52, 109, 183
Breast Imaging Reporting and Data System (BIRADS), 37
defined, 242
functional magnetic resonance imaging, 83
proteins, 122, 123
Incidence and prevalence, 1-2, 15, 18, 184, 226, 231
see also Mortality
defined, 242, 245
genetic testing, 112
male breast cancer, 218(n.6)
Income, see Socioeconomic status
India, 33
Industry Forum & Workshop on Biomedical Imaging in Oncology, 24
Information dissemination,
see Databases; Internet; Professional education
Information Storage, Curation, Analysis, and Retrieval program, 141
Informed consent, 11, 13, 113, 129-130
Infrared thermography, 62-63, 91-93
Institutional review boards, 151(n.19)
Insulin-like growth factor type 1, 128-129
Insurance
see also Health insurance; Managed care; Medicaid; Medicare
malpractice, 215
Intellectual property, 12, 113, 114, 130-131, 134, 245
Interdisciplinary approaches, see Multidisciplinary approaches
International perspectives
see also specific countries
breast self-examination, 29
clinical breast examination, 33
electrical potential measurements, 94-95
electronic palpation, 98
genetic testing, 113-114
magnetic resonance imaging (MRI), 82
mammography screening, 35, 42, 52
mortality, 52, 223
Internet
digital mammography, FDA approval, 160(n.26)
imaging technology, 135(n.1)
NCI forum, 135(n.2)
NCI funding, 137(n.6)
telemammography, 71, 246
venture capital, 146-148
Interval cancers, 38, 44, 72, 184
Invasive breast cancer, 54, 242
see also Metastasis
core-needle biopsies, 38
ductal carcinoma in situ (DCIS), 46, 48, 51-52, 242
incidence, 1, 15, 52
lobular carcinoma in situ (LCIS), 48, 81, 242
magnetic resonance imaging (MRI), 81
preinvasive lesions, 13
treatment, 51-52
Investigational device exemptions (IDEs), 151, 166, 170, 171
Iran, 98
Ireland, 113-114
see also Computer-aided detection or diagnosis; Contrast agents; Hall effect imaging; Magnetic resonance imaging; Magnetic resonance spectroscopy; Mammography; Microwave imaging; Optical imaging; Scintimammography; Thermography; Tomography
disabled persons, 19, 182, 205-206, 216-217
expenditures on, 149
funding, general, 21-22, 136, 141, 146, 148-149, 165, 230
infrared thermography, 62-63, 91-93
magnetomammography, 57, 64-65, 101-102
Medicare coverage, 173
National Electrical Manufacturers' Association, 135, 150
virtual reality, 97, 102, 247
Immigrants, 208
Immunohistochemistry, 7, 45, 52, 109, 183
Breast Imaging Reporting and Data System (BIRADS), 37
defined, 242
functional magnetic resonance imaging, 83
proteins, 122, 123
Incidence and prevalence, 1-2, 15, 18, 184, 226, 231
see also Mortality
defined, 242, 245
genetic testing, 112
male breast cancer, 218(n.6)
Income, see Socioeconomic status
India, 33
Industry Forum & Workshop on Biomedical Imaging in Oncology, 24
Information dissemination,
see Databases; Internet; Professional education
Information Storage, Curation, Analysis, and Retrieval program, 141
Informed consent, 11, 13, 113, 129-130
Infrared thermography, 62-63, 91-93
Institutional review boards, 151(n.19)
Insulin-like growth factor type 1, 128-129
Insurance
see also Health insurance; Managed care; Medicaid; Medicare
malpractice, 215
Intellectual property, 12, 113, 114, 130-131, 134, 245
Interdisciplinary approaches, see Multidisciplinary approaches
International perspectives
see also specific countries
breast self-examination, 29
clinical breast examination, 33
electrical potential measurements, 94-95
electronic palpation, 98
genetic testing, 113-114
magnetic resonance imaging (MRI), 82
mammography screening, 35, 42, 52
mortality, 52, 223
Internet
digital mammography, FDA approval, 160(n.26)
imaging technology, 135(n.1)
NCI forum, 135(n.2)
NCI funding, 137(n.6)
telemammography, 71, 246
venture capital, 146-148
Interval cancers, 38, 44, 72, 184
Invasive breast cancer, 54, 242
see also Metastasis
core-needle biopsies, 38
ductal carcinoma in situ (DCIS), 46, 48, 51-52, 242
incidence, 1, 15, 52
lobular carcinoma in situ (LCIS), 48, 81, 242
magnetic resonance imaging (MRI), 81
preinvasive lesions, 13
treatment, 51-52
Investigational device exemptions (IDEs), 151, 166, 170, 171
Iran, 98
Ireland, 113-114
J
Japan, 113-114
K
Kaiser Permanente, 177
Keratins, 123, 128
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 282
L
Labeling,
152,
161,
165
Lavage, 7, 127, 156, 161, 238
Legal issues, see Discrimination, genetic; Food and Drug Administration; Informed consent; Intellectual property; Malpractice; Privacy and confidentiality;
Legislation
see also Regulatory issues
Breast and Cervical Cancer Mortality Prevention Act, 211
Breast and Cervical Treatment Act, 14, 236
Clinical Laboratory Improvement Amendments, 113, 169
confidentiality/genetic discrimination, 11, 227, 233
Defense Appropriations Act, 143
Federal Food, Drug, and Cosmetic Act, 151(n.18), 167-168
Food and Drug Administration Modernization Act, 152
Health Insurance Portability Act, 112
Mammography Quality Standards Act, 14, 34-35, 193-194, 222, 236
Medical Device Amendment, 92, 151, 153, 156-157, 158
National Health Planning and Resources Development Act, 169
Social Security Act, 170
uninsured women, screening of, 10, 230, 236
Lewin Group, 173
Life expectancy, clinical trials,
standards, 26, 27
elderly women, 40
Lobular carcinoma in situ (LCIS), 46-48, 81, 242
Loss of heterozygosity, see Heterozygosity
Lumpectomies, 82, 83
Lymphoma, 44, 121
Lavage, 7, 127, 156, 161, 238
Legal issues, see Discrimination, genetic; Food and Drug Administration; Informed consent; Intellectual property; Malpractice; Privacy and confidentiality;
Legislation
see also Regulatory issues
Breast and Cervical Cancer Mortality Prevention Act, 211
Breast and Cervical Treatment Act, 14, 236
Clinical Laboratory Improvement Amendments, 113, 169
confidentiality/genetic discrimination, 11, 227, 233
Defense Appropriations Act, 143
Federal Food, Drug, and Cosmetic Act, 151(n.18), 167-168
Food and Drug Administration Modernization Act, 152
Health Insurance Portability Act, 112
Mammography Quality Standards Act, 14, 34-35, 193-194, 222, 236
Medical Device Amendment, 92, 151, 153, 156-157, 158
National Health Planning and Resources Development Act, 169
Social Security Act, 170
uninsured women, screening of, 10, 230, 236
Lewin Group, 173
Life expectancy, clinical trials,
standards, 26, 27
elderly women, 40
Lobular carcinoma in situ (LCIS), 46-48, 81, 242
Loss of heterozygosity, see Heterozygosity
Lumpectomies, 82, 83
Lymphoma, 44, 121
M
Magnetic resonance imaging (MRI), 17, 56, 57, 60-61, 79-84, 91, 134, 150, 195, 224-225
see also Contrast agents
biopsies and, 38
clinical trials, 5, 61, 82, 83, 84, 218, 225
defined, 243
elastography, 78-79, 82
FDA approval, 4, 5, 79, 159, 224
functional, 93
Internet, 135(n.1)
recurrent cancers, 60, 82
sensitivity, 81, 82, 91
specificity, 78-79, 81, 91
standards, 82, 219
Magnetic resonance spectroscopy (MRS), 56, 57, 60-61, 84-85
defined, 243
FDA approval, 4, 57
NCI initiatives, 61, 82
Magnetomammography, 57, 64-65, 101-102
Males, see Men
Malpractice, 40, 193, 215-217, 220
Mammography, 29, 33-53, 56, 102-103, 136, 143, 150, 158, 181, 192, 193, 195, 202-223, 225, 229-232
see also Contrast agents; Digital mammography; Film-screen mammography; Patient education and outreach
adoption and dissemination, 9
age factors, 2, 14
benign tumors, 2, 36, 55
computer-aided detection and, 163
cost of, 10, 14, 36, 40-41, 103, 186, 193-194, 211-213, 219, 227, 231, 235-236
defined, 239, 243, 246
disabled persons, 19, 182, 205-206, 216-217
electrical impedance and, 96
electronic palpation and, 97
expenditures on, 149
false negatives, 2, 40, 50, 53, 71, 75, 156, 163, 183-184, 223, 240
false positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
film-screen mammography
full-field digital mammography
historical perspectives, 10, 15-17, 200-204, 217, 219
Internet, 135(n.1)
lesion classification, 2
magnetic resonance imaging (MRI) and, 61, 80-81, 82
magnetomammography, 57, 64-65, 101-102
Medicare coverage, 170
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 283
military technology applied to, 91, 143mortality rates and, 38, 43. 49-51, 52, 55, 103
nipple aspiration fluid and, 127
Pro*Duct catheter and, 161
racial/ethnic factors in use of, 206, 207, 208
sensitivity, general, 9, 12, 25, 53, 55, 136, 219
socioeconomic status, 206, 207, 208
specificity, general, 9, 12, 25, 38-39, 53, 136
standards, general, 14, 34-37 (passim), 102-103, 193-194, 206, 218-219, 222, 236
state health insurance mandates, 175, 232
telemammography, 71, 246
thermoacoustic computed tomography and, 98, 99
tissue density, 2, 37, 43, 55, 68-69, 136, 223
TransScan electrical impedance imaging and, 64, 96, 161-162
Mammography Quality Standards Act (MQSA), 14, 34-35, 193-194, 222, 236
Mammotome, see Vacuum-assisted biopsies
Managed care, 8, 176-177
Mastectomy, 5, 44, 112, 245
The Mathematics and Physics of Emerging Biomedical Imaging, 56
Medicaid, 10, 13-14, 167, 169, 211, 230, 235-236
defined, 243
Medical Coverage Advisory Committees (MCACs), 172, 173
Medical Device Amendment, 92, 151, 153, 156-157, 158
Medical Technology Leadership Forum, 189
Medicare, 13-14, 169-174, 190, 193-195, 199, 210, 215(n.5), 232, 235-236
defined, 243
Men
breast cancer incidence, 218(n.6)
prostate cancer, 175, 180-181, 232
Menstrual cycle, 43, 128-129, 218
definitions, 243
electrical impedance, 162
menopause, 43, 127, 129, 218, 243
Meta-analysis, 34, 82, 174, 177-178, 179, 209
defined, 243
Metastasis, 19, 29, 34, 38, 40, 41, 46, 49, 50-54 (passim), 61, 104, 117-118, 122, 123, 125, 137, 142, 209, 225, 226
defined, 243
magnetic resonance imaging (MRI), 82
Methylation, 6, 119, 243
MIBI see Scintimammography; Technetium-99m sestamibi
Microwave imaging, 23, 56, 57, 64-65, 99-100
Mitochondrial DNA, 127
Molecular biology, 11, 105-106, 137, 226-227, 244
see also Biomarkers; Genetic factors; Immunohistochemistry; Proteins
carcinoembryonic antigens, 123, 127-128, 181
funding for research, 20, 21, 137, 142
Mortality, 1-2, 5, 9, 13, 18, 51, 103, 131, 151, 204, 210, 223, 229
see also Life expectancy
breast self-examination and, 29(n.4)
clinical trials, 14, 19, 26, 34, 43, 154, 222-223, 228, 235
defined, 244
disease-specific, 181, 184, 190, 235
genetic testing, 112, 226
international perspectives, 52, 223
mammography and, 38, 43. 49-51, 52, 55, 103
metastasis, 49
mRNA, 119, 121-122, 243
M1000 ImageChecker, 163
Multidisciplinary approaches, 134, 137, 138-139, 177
coordination of federal research, 24, 135, 143, 165, 191
Unconventional Innovations Program, 29, 139, 141, 142
Mutation, 6, 105, 107-124, 127, 227, 241
ataxia telangiectasia, 45
breast cancer-associated tumor suppressor gene (BRCA), 6, 44, 45-46, 108, 110-114, 224, 227, 238
defined, 244, 246
inherited, 44
p53 tumor suppressor genes, 114, 128, 227
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 284
N
National Action Plan on Breast Cancer,
112
National Aeronautics and Space Administration, 17, 24, 135
National Breast and Cervical Cancer Early Detection Program, 10
National Breast Cancer Coalition, 113
National Cancer Institute (NCI), 12, 136-137, 197
Breast Cancer Surveillance Consortium, 13, 14, 191-192, 229-230, 235, 236
Cancer Genome Anatomy Project (CGAP), 106-107, 131, 136
clinical trials, 13, 14, 181, 190-192, 200, 229-230, 234, 235, 236
computer-aided detection, 56, 134
confidentiality, 130
databases, 141, 191-192
effectiveness/efficacy surveillance, 13, 190-192, 235
Federal Multi-Agency Consortium to Improve Women's Health, 135, 136
funding for research, various programs, 20, 21, 24, 130, 131, 132, 135, 136-142, 228
magnetic resonance imaging, 61, 82
novel imaging technologies, 134, 165
screening mammography, general, 34, 202
specimen banks, 130, 131
National Center for Health Care Technology, 169
National Electrical Manufacturers' Association, 135, 150
National Health Care Financing Administration, 135
National Health Planning and Resources Development Act, 169
National Human Genome Research Institute, 112
National Institute of Standards and Technology, 143-146
National Institutes of Health (NIH), 172, 175, 189(n.11), 201
see also National Cancer Institute
funding for research, various programs, 20, 21, 133, 141, 143
genetic testing, 114
National Mammography Database, 36(n.10)
National Science Foundation, 135
National Surgical Adjuvant Breast and Bowel Project, 48
Nipple aspiration, 7, 126-127
defined, 244
Northern analysis, 6, 108
Nuclear medicine, general, 134, 150
Internet, 135(n.1)
National Aeronautics and Space Administration, 17, 24, 135
National Breast and Cervical Cancer Early Detection Program, 10
National Breast Cancer Coalition, 113
National Cancer Institute (NCI), 12, 136-137, 197
Breast Cancer Surveillance Consortium, 13, 14, 191-192, 229-230, 235, 236
Cancer Genome Anatomy Project (CGAP), 106-107, 131, 136
clinical trials, 13, 14, 181, 190-192, 200, 229-230, 234, 235, 236
computer-aided detection, 56, 134
confidentiality, 130
databases, 141, 191-192
effectiveness/efficacy surveillance, 13, 190-192, 235
Federal Multi-Agency Consortium to Improve Women's Health, 135, 136
funding for research, various programs, 20, 21, 24, 130, 131, 132, 135, 136-142, 228
magnetic resonance imaging, 61, 82
novel imaging technologies, 134, 165
screening mammography, general, 34, 202
specimen banks, 130, 131
National Center for Health Care Technology, 169
National Electrical Manufacturers' Association, 135, 150
National Health Care Financing Administration, 135
National Health Planning and Resources Development Act, 169
National Human Genome Research Institute, 112
National Institute of Standards and Technology, 143-146
National Institutes of Health (NIH), 172, 175, 189(n.11), 201
see also National Cancer Institute
funding for research, various programs, 20, 21, 133, 141, 143
genetic testing, 114
National Mammography Database, 36(n.10)
National Science Foundation, 135
National Surgical Adjuvant Breast and Bowel Project, 48
Nipple aspiration, 7, 126-127
defined, 244
Northern analysis, 6, 108
Nuclear medicine, general, 134, 150
Internet, 135(n.1)
O
Observational studies, 34, 179-180, 244
Occult tumors, see Asymptomatic (occult) tumors
Office of Bioengineering, Bioimaging, and Bioinformatics, 141
Office of Medical Applications of Research, 175
Office of Technology and Industrial Relations, 137, 138-139
Office of Technology Assessment, 169
Office on Women's Health (OWH), 134, 135
Oligonucleotides, 110, 142, 244
Optical imaging, 56, 57, 62-63, 88-91
defined, 244
biopsies, 89, 91
electronic palpation, 97
FDA approval, 4, 57, 89, 91
Optical spectroscopy, 57, 62-63, 89
Optical tomography, 62-63, 90
OTIR, 20
Outreach, see Patient education and outreach
Overtreatment/overdiagnosis, 2, 5, 28, 29, 46-48, 55, 132, 204
biopsies, unnecessary, 29, 55, 84, 90, 132, 134
breast self-examination, 29
defined, 244
P
Pacific Center for Ethics and Applied Biology, 19
Pain and discomfort, 10, 12, 231
see also Psychological/emotional factors
biopsies, 39
optical imaging, 90
Palpation, 27, 53, 64, 78, 97-98, 157, 223
see also Self-examination
electronic, 4, 33, 57, 63, 64-65, 94, 96-98, 240
scintimammography and, 86
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 285
Pap smears, 1, 15, 84, 125, 175, 194, 196, 204, 206Patents, see Intellectual property
Patient education and outreach, 9-10, 199-213, 219-220
counseling, 113, 206
elderly persons, 202, 203, 204, 205-206, 208-209
genetic testing, 112-113
informed consent, 11, 13, 113, 129-130
Pattern recognition, 56, 102, 134
Peptides, 125
p53 tumor suppressor genes, 114, 128, 227
Pharmaceuticals, 229
chemotherapy, 87, 125
contrast agents, 59, 60, 61, 78, 81-82, 83, 91, 103, 161, 239, 241-242
estrogen replacement, 43, 122, 128
expenditures on, 148-149
radiopharmaceuticals, 21, 85-86, 88; see also “contrast agents” supra
scintimammography, multidrug resistance, 87
Phase-contrast X-ray imaging, 71, 73
Phased Innovation Award, 20, 21
Phased Technology Application Award, 21
Physicians, 209, 210, 230
age of patients, 208-209
FDA approved techniques, 165
histological diagnosis, 49
malpractice, 40, 193, 215-217, 220
Medicare reimbursement, 193
technology adoption, 165, 167, 188-189
World Health Organization clinical trial guidelines, 19, 26
PMA, see Premarketing approval
Polymerase chain reaction (PCR), 6, 108, 118, 119, 122, 131
defined, 245
Polymorphisms, 6, 108, 118, 128
defined, 245
Positive predictive value, 25, 40, 55, 75, 245
false negatives, 2, 40, 50, 53, 71, 75, 112, 156, 163, 183-184, 223, 240
false positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
Positron emission tomography, 4, 56, 57, 62-63, 88, 135(n.1)
defined, 245
Poverty, see Socioeconomic status
Pregnancy, scintimammography, 86
Premarketing approval (PMA), 94, 96, 97, 151, 152, 157, 159, 160, 163, 164, 171
Premarket notification, 151, 153
Prevalence, see Incidence and prevalence
Preventive Services Task Force, 29(n.3), 173-174, 209
Privacy and confidentiality, 11, 112, 129-130, 227, 233
Private sector, 8, 17, 116, 133-134, 146-149, 163-164, 172, 176-177, 189, 228
see also Health insurance; Intellectual property; Regulatory issues
Advanced Technology Program, 143-146
biotechnology, 17, 149
foundation programs, funding, 23-24
specimen banks, 130-131
venture capital, 146-148, 149, 164
Pro*Duct catheter, 161
Professional education, 9-10, 190, 199, 211, 213-215, 220, 236
see also Specimen banks
funding, 14, 236
Prognosis, 104
see also Life expectancy
databases, 191, 192
defined, 245
DNA arrays, 121
fluorescent in situ hybridization, 118
magnetic resonance imaging (MRI), 82-83
thermography, 91
Prostate cancer, 175, 180-181, 232
Proteins, 5, 7, 11, 109, 114, 117, 119, 122-124, 226, 233, 245
serum, 105, 122, 127, 128-129, 132
Proton magnetic resonance spectroscopy,
see Magnetic resonance spectroscopy
Psychological/emotional factors
see also Pain and discomfort
biopsies, general, 156
BRCA mutations, 112
false positives, 39, 183
PTEN, see Tumor suppressor gene
Public education,
see Patient education and outreach
Public Health Service
see also Agency for Healthcare Research and Quality
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 286
Office of Women's Health (OWH), 134, 135Preventive Services Task Force, 29(n.3), 173-174, 209
Q
Quality-adjusted life years (QALYs), 185, 186
Quality control
see also Regulatory issues; Standards
Agency for Healthcare Research and Quality, 174
evidence, 180
mammogram interpretation, 2, 5
NCI programs, 191
Quality of life, other, 185-186
see also Pain and discomfort; Psychological/emotional factors
R
Race/ethnicity
databases, 192
mammography use, 206, 207, 208
Radiation doses, 55, 156, 201
reduction in, 17, 224
scintimammography, 86
Radiation sensitivity, 9, 12, 15, 44-46
Radiation therapy, 51-52, 150
Radioactive antibodies, 62-63
Randomization
clinical trials, 1, 2, 15, 26, 33, 179, 180-181, 184, 190-191, 197, 200, 217, 222-223, 228-229
screening mammography, 34, 35, 42, 43, 49, 222-223
defined, 245
observational studies, 180
Recurrent breast cancer
biomarkers, 125, 142
ductal carcinoma in situ, 51-52
magnetic resonance imaging (MRI), 60, 82
Regulatory issues, 8-9, 10, 53, 133, 135, 151, 164, 222, 225, 227
see also Food and Drug Administration; Legislation; Standards
electrical potential measurements, Europe, 94-95
labeling, 152, 161, 165
Reverse transcription, 108, 119, 246
Riboflavin carrier protein, 128
Risk assessment, 28, 49, 54, 107, 217-219, 226, 227, 232
see also Age factors; Family factors; Race/ethnicity
biomarkers, 132
clinical practice guidelines, 217-219
cost-effectiveness, 28-29
definitions, 28, 237, 245, 246
elderly persons, 113, 231
FDA approval and, 151
germ-line mutations, 107-116
radiation sensitivity, 44-46
scintimammography, 86
thermography, 91
Risk reduction, 5
RNA, 108, 119, 121-122, 244
mRNA, 119, 121-122, 243
Russia, 29
S
Scintimammography, 56, 57, 60-61, 85-87, 101-102
defined, 246
FDA approval, 4, 57, 61, 85, 87, 224
sensitivity, 86, 101-102
specificity, 85, 86
Self-examination (BSE), 33-34
defined, 238
education and outreach, 200
intervals, 1, 29, 202, 203, 204
pad to assist, FDA approved, 33
Sensitivity, 182, 183-184, 197, 229, 231, 242
biomarkers, 109
cost of technology and, 168
digital mammography, 70, 136, 230
electrical impedance measurements, 162
electrical potential measurements, 94
false negatives, 2, 40, 50, 53, 71, 75, 112, 156, 163, 183-184, 223, 240
false positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
FDA approval process, 154, 161, 162, 165, 234
magnetic resonance imaging (MRI), 81, 82, 91
magnetomammography, 101-102
mammography, general, 9, 12, 25, 53, 55, 103, 136, 219
optical imaging, 88, 91
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 287
positron emission tomography, 88Pro*Duct catheter, 161
scintimammography, 86, 101-102
ultrasound, 82
Sexual sensitivity, biopsies, 39
Single-photon emission computed tomography, 86, 244-245
Small Business Innovative Research, 137
Small Business Technology Transfer Research, 137
SNP Consortium Ltd., 116
Social Security Act, 170
Society of Breast Imaging, 14, 212, 213
Socioeconomic status, 182, 206, 207, 208
Medicaid, 10, 13-14, 167, 169, 211, 230, 235
Specificity, 9, 12, 25, 38-39, 53, 103, 136, 219, 229, 230
biomarkers, 109
computer-aided detection, 74
defined, 246
electrical impedance measurements, 162
electrical potential measurements, 94
false positives, 2, 38-39, 53, 70-71, 74, 156, 183-184, 240
FDA approval process, 154, 161, 162, 165, 234
magnetic resonance imaging (MRI), 78-79, 81, 91
mammography, general, 9, 12, 25, 38-39, 53, 136
optical imaging, 88, 91
positron emission tomography, 88
Pro*Duct catheter, 161
scintimammography, 85, 86
ultrasound, 77, 78-79
Specimen banks, 5, 11-12, 13, 106-107, 130-131
defined, 246
funding, 11, 130, 131, 132, 233-234
Spectroscopy, 7, 142, 182, 183-184, 197, 231
see also Elastic scattering spectroscopy; Electrical impedance tomography system; Magnetic resonance spectroscopy; Optical spectroscopy
Standards, 33, 178-184, 190, 197
see also Clinical practice guidelines; Cost and cost-effectiveness factors; Effectiveness; Efficacy; Food and Drug Administration; Regulatory issues; Sensitivity; Specificity
biomarkers, 107, 130
clinical trials, general, 19, 26, 151, 178, 181-184
data, 107, 192
electronic palpation, 97
genetic information, use of, 112, 227, 233
ideal screening tool, 232-233
magnetic resonance imaging (MRI), 82, 219
mammography, general, 14, 34-37(passim), 102-103, 193-194, 206, 218-219, 222, 236
Medicare coverage, 172-173
National Institute of Standards and Technology, 143-146
periodic health examinations, 182
pharmaceuticals, 229
specimen banks, 130
state health insurance mandates, 175
tissue density classification, 218-219
World Health Organization clinical trial guidelines, 19, 26
State Children's Insurance Program, 169
State government
health insurance coverage, 175, 232
Medicaid, 10
Steroids, 125
Superconducting quantum interference device (SQUID), magnetomammography, 57, 64-65, 101-102
Surgery
see also Biopsies
breast-conserving therapy, 81, 161
breast self-examination and, 29
ductal carcinoma in situ (DCIS), 51-52
elastic scattering spectroscopy (ESS) and, 90
lumpectomies, 82, 83
mastectomy, 5, 44, 112, 245
Medicare coverage, 173
Susan G. Komen Breast Cancer Foundation, 23
T
Technetium-99m sestamibi (MIBI), 61, 87, 102
see also Scintimammography
Telemammography, 71, 246
Texture analysis, 56
Suggested Citation:
"Index." Institute of Medicine and National Research Council. 2001. Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer. Washington, DC: The National Academies Press.
doi: 10.17226/10030.
Page 288
Thermoacoustic computed tomography, 57, 64-65, 98-99FDA approval, 4, 57, 224
Thermography, 57, 91-93
defined, 247
FDA approval, 4, 63, 92, 93, 150
infrared thermography, 62-63, 91-93
Thermotherapy, 83, 247
Three-dimensional interactive visualization, 66-67, 102
Internet, 135(n.1)
Tissue density, 2, 37, 43, 55, 136, 223
classification standards, 218-219
digital mammography, 68-69, 136
microwave imaging, 100
nipple aspiration fluid, 127
scintimammography, 86
ultrasound, 77
Tissue specimen banks, see Specimen banks
Tomography
computer-aided, 4, 57, 73, 86, 150, 195, 224, 239, 244-245
defined, 247
electrical impedance tomography system, 95-96
funding for research, 23
optical tomography, 62-63, 90
positron emission tomography, 4, 56, 57, 62-63, 88, 135(n.1), 245
single-photon emission computed tomography, 86, 244-245
thermoacoustic computed tomography, 4, 57, 64-65, 98-99. 224
tuned aperture computed tomography, 73
Transcription, 108, 110, 119, 121, 122, 246, 247
Transillumination, 88-89
TransScan electrical impedance imaging, 64, 96, 161-162
Trials of Imaging Agents, 21
Tumor markers, see Biomarkers
Tumor Marker Utility Grading System, 124
Tumor suppressor gene, 114, 117, 119, 247
Tuned aperture computed tomography (TACT), 73
U
Ultrasound, 5, 17, 38, 39, 56, 57, 58-59, 76-79, 134, 150, 195, 211, 225
cost of, 44, 82, 86, 101, 187
defined, 247
elastography, 4, 57, 78-79, 240
expenditures on, 149
FDA approval, 4, 224
Hall effect imaging, 57, 64-65, 100-101
Internet, 135(n.1)
magnetic resonance imaging (MRI) and, 82
sensitivity, 82
specificity, 77, 78-79
thermoacoustic computed tomography, 4, 57, 64-65, 98-99, 224
Unconventional Innovations Program, 29, 139, 141, 142
United Kingdom, 188
magnetic resonance imaging (MRI), 82
V
Vacuum-assisted biopsies, 38
Venture capital, 146-148, 149, 164
Virtual reality, 97, 102, 247
W
Whitaker Foundation, 23
Workshop on Sensors for Bio-Molecular Signatures, 24
Workstations and displays, 21, 56, 68-69
World Health Organization, 177
clinical trial guidelines, 19, 26
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