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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


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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

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Page 274 Asymptomatic (occult) tumors, 19, 40, 43, 46, 48, 50, 77, 230      defined, 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

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Page 275 California Breast Cancer Research Program, 23 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

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Page 276 Comparative Genomic Hybridization, 6, 108 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 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

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Page 277 Defense Advanced Research Projects Agency, 139 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 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

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Page 278      Health Care Financing Administration (HFCA), 170, 171, 173      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 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

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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

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Page 280      clinical trials of genetic testing, 112-113, 114      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 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

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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 J Japan, 113-114 K Kaiser Permanente, 177 Keratins, 123, 128

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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 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

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Page 283      military technology applied to, 91, 143      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

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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) 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

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Page 285 Pap smears, 1, 15, 84, 125, 175, 194, 196, 204, 206 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

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Page 286      Office of Women's Health (OWH), 134, 135      Preventive 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

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Page 287      positron emission tomography, 88      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 T Technetium-99m sestamibi (MIBI), 61, 87, 102      see also Scintimammography Telemammography, 71, 246 Texture analysis, 56

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Page 288 Thermoacoustic computed tomography, 57, 64-65, 98-99      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 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