Assessing the stand-alone sensitivity of computer-aided detection with cancer cases from the Digital Mammographic Imaging Screening Trial.

OBJECTIVE: The purpose of this study was to assess the sensitivities and false-detection rates of two computer-aided detection (CADe) systems when applied to digital or film-screen mammograms in detecting the known breast cancer cases from the Digital Mammographic Imaging Screening Trial (DMIST) breast cancer screening population. MATERIALS AND METHODS: Available film-screen and digital mammograms of 161 breast cancer cases from DMIST were analyzed by two CADe systems, iCAD Second-Look and R2 ImageChecker. Three experienced breast-imaging radiologists reviewed the CADe marks generated for each available cancer case, recording the number and locations of CADe marks and whether each CADe mark location corresponded with the known location of the cancer. RESULTS: For the 161 cancer cases included in this study, the sensitivities of the DMIST reader without CAD were 0.43 (69/161, 95% CI 0.35-0.51) for digital and 0.41 (66/161, 0.33-0.49) for film-screen mammography. The sensitivities of iCAD were 0.74 (119/161, 0.66-0.81) for digital and 0.69 (111/161, 0.61-0.76) for film-screen mammography, both significantly higher than the DMIST study sensitivities (p < 0.0001 for both). The average number of false CADe marks per case of iCAD was 2.57 (SD, 1.92) for digital and 3.06(1.72) for film-screen mammography. The sensitivity of R2 was 0.74 (119/161, 0.66-0.81) for digital, and 0.60 (97/161, 0.52-0.68) for film-screen mammography, both significantly higher than the DMIST study sensitivities (p < 0.0001 for both). The average number of false CADe marks per case of R2 was 2.07 (1.57) for digital and 1.52 (1.45) for film-screen mammography. CONCLUSION: Our results suggest the use of CADe in interpretation of digital and film-screen mammograms could lead to improvements in cancer detection.

Use of BI-RADS 3-probably benign category in the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial.

PURPOSE: To determine (a) how often the Breast Imaging Reporting and Data System (BI-RADS) category 3 was used in the American College of Radiology Imaging Network (ACRIN) Digital Mammographic Imaging Screening Trial (DMIST), either at the time of screening mammography or after work-up, (b) how often subjects actually returned for the recommended follow-up examination, and (c) the rate and stages of any malignancies subsequently found in subjects for whom short-term interval follow-up was recommended. MATERIALS AND METHODS: This study was approved by the Institutional Review Board at all institutions where subjects were enrolled. All subjects participating in DMIST gave informed consent and the study was HIPAA-compliant. A total of 47,599 DMIST-eligible and evaluable subjects, all of whom consented to undergo both digital and screen-film mammography, were included in this analysis. Cases referred for short-term interval follow-up based on digital, screen-film, or both imaging examinations were determined. Compliance with the recommendations and the final outcome (malignancy diagnosis at biopsy or no malignancy confirmed through follow-up) of each evaluable case were determined. RESULTS: A total of 1114 of the 47,599 (2.34%) subjects had tumors assigned a BI-RADS 3 category and were recommended to undergo short-interval follow-up. In this study, 791 of 1114 (71%) of the subjects were compliant with the recommendation and returned for short-interval follow-up. Of the women who did not return for short-interval follow-up, 70% (226 of 323) did return for their next annual mammography. Among all subjects whose tumors were assigned a BI-RADS 3 category either at screening mammography or after additional work-up, nine of 1114 (0.81%) were found to have cancer. Of the nine biopsy-proved cancers, six were invasive cancers and three were ductal carcinoma in situ stage Tis-T1c. The invasive cancers were all less than 2 cm in size. CONCLUSION: In DMIST, radiologists used the BI-RADS 3 classification infrequently (2.3% of patients). Tumors assigned a BI-RADS 3 category had a low rate of malignancy. The relatively high rate of noncompliance with short-interval follow-up recommendations (323 of 1114, or 29%) supports prior recommendations that radiologists thoroughly evaluate lesions before placing them in this category.

Sonographic features of gynecomastia.

OBJECTIVE: The purpose of this study was to identify sonographic features of gynecomastia. METHODS: A retrospective analysis was performed on all male patients with breast symptoms imaged with breast sonography over a 5-year period. Breast sonograms in 158 men were jointly reviewed by 3 investigators. Sonograms were assessed for the presence or absence of a mass: (1) if mass present, (a) location of the mass, (b) vascularity, (c), axis, (d) appearance of posterior tissues, and (e) tissue echo texture; and (2) if mass absent, anteroposterior (AP) depth at the nipple (increased if >1 cm). RESULTS: Of the 237 men with breast symptoms, 79 with only mammography were excluded. Of the 158 who had sonography with or without mammography, 5 without gynecomastia were also excluded. A total of 153 men included in the study presented with pain (n = 38), a lump (n = 95), both pain and a lump (n = 17), or nipple discharge (n = 3). Nine of 153 with gynecomastia had a biopsy. A total of 219 sonographic examinations were performed, which revealed 73 masses (33%): 20 (27%) nodular, 20 (27%) poorly defined, and 33 (45%) flame shaped. All masses were retroareolar, with 57 (78%) hypoechoic, 54 (73%) avascular, 60 (82%) parallel to the chest wall, and 47 (64%) without posterior enhancement or shadowing. Of the 146 without masses (67%), 141 (97%) had increased AP depth at the nipple. CONCLUSIONS: Gynecomastia is a clinical diagnosis, and mammography is the primary imaging modality when indicated. However, if sonography is used when mammography is declined or when mammography is inconclusive, it is important to recognize the various described patterns of gynecomastia to avoid unnecessary biopsy based on sonographic findings.

Cancer cases from ACRIN digital mammographic imaging screening trial: radiologist analysis with use of a logistic regression model.

PURPOSE: To determine which factors contributed to the Digital Mammographic Imaging Screening Trial (DMIST) cancer detection results. MATERIALS AND METHODS: This project was HIPAA compliant and institutional review board approved. Seven radiologist readers reviewed the film hard-copy (screen-film) and digital mammograms in DMIST cancer cases and assessed the factors that contributed to lesion visibility on both types of images. Two multinomial logistic regression models were used to analyze the combined and condensed visibility ratings assigned by the readers to the paired digital and screen-film images. RESULTS: Readers most frequently attributed differences in DMIST cancer visibility to variations in image contrast--not differences in positioning or compression--between digital and screen-film mammography. The odds of a cancer being more visible on a digital mammogram--rather than being equally visible on digital and screen-film mammograms--were significantly greater for women with dense breasts than for women with nondense breasts, even with the data adjusted for patient age, lesion type, and mammography system (odds ratio, 2.28; P < .0001). The odds of a cancer being more visible at digital mammography--rather than being equally visible at digital and screen-film mammography--were significantly greater for lesions imaged with the General Electric digital mammography system than for lesions imaged with the Fischer (P = .0070) and Fuji (P = .0070) devices. CONCLUSION: The significantly better diagnostic accuracy of digital mammography, as compared with screen-film mammography, in women with dense breasts demonstrated in the DMIST was most likely attributable to differences in image contrast, which were most likely due to the inherent system performance improvements that are available with digital mammography. The authors conclude that the DMIST results were attributable primarily to differences in the display and acquisition characteristics of the mammography devices rather than to reader variability.

Diagnostic accuracy of digital versus film mammography: exploratory analysis of selected population subgroups in DMIST.

PURPOSE: To retrospectively compare the accuracy of digital versus film mammography in population subgroups of the Digital Mammographic Imaging Screening Trial (DMIST) defined by combinations of age, menopausal status, and breast density, by using either biopsy results or follow-up information as the reference standard. MATERIALS AND METHODS: DMIST included women who underwent both digital and film screening mammography. Institutional review board approval at all participating sites and informed consent from all participating women in compliance with HIPAA was obtained for DMIST and this retrospective analysis. Areas under the receiver operating characteristic curve (AUCs) for each modality were compared within each subgroup evaluated (age < 50 vs 50-64 vs >or= 65 years, dense vs nondense breasts at mammography, and pre- or perimenopausal vs postmenopausal status for the two younger age cohorts [10 new subgroups in toto]) while controlling for multiple comparisons (P < .002 indicated a significant difference). All DMIST cancers were evaluated with respect to mammographic detection method (digital vs film vs both vs neither), mammographic lesion type (mass, calcifications, or other), digital machine type, mammographic and pathologic size and diagnosis, existence of prior mammographic study at time of interpretation, months since prior mammographic study, and compressed breast thickness. RESULTS: Thirty-three centers enrolled 49 528 women. Breast cancer status was determined for 42,760 women, the group included in this study. Pre- or perimenopausal women younger than 50 years who had dense breasts at film mammography comprised the only subgroup for which digital mammography was significantly better than film (AUCs, 0.79 vs 0.54; P = .0015). Breast Imaging Reporting and Data System-based sensitivity in this subgroup was 0.59 for digital and 0.27 for film mammography. AUCs were not significantly different in any of the other subgroups. For women aged 65 years or older with fatty breasts, the AUC showed a nonsignificant tendency toward film being better than digital mammography (AUCs, 0.88 vs 0.70; P = .0025). CONCLUSION: Digital mammography performed significantly better than film for pre- and perimenopausal women younger than 50 years with dense breasts, but film tended nonsignificantly to perform better for women aged 65 years or older with fatty breasts.

Issues to consider in converting to digital mammography.

This article outlines the reasons that many radiology practices are converting to digital mammography. In addition, it provides basic information about the issues that must be considered in making the transformation. These issues include technical matters regarding image display, storage, and retrieval as well as clinical and ergonomic considerations.

Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy.

Medical procedures in outpatient settings have limited options of managing pain and anxiety pharmacologically. We therefore assessed whether this can be achieved by adjunct self-hypnotic relaxation in a common and particularly anxiety provoking procedure. Two hundred and thirty-six women referred for large core needle breast biopsy to an urban tertiary university-affiliated medical center were prospectively randomized to receive standard care (n=76), structured empathic attention (n=82), or self-hypnotic relaxation (n=78) during their procedures. Patients' self-ratings at 1 min-intervals of pain and anxiety on 0-10 verbal analog scales with 0=no pain/anxiety at all, 10=worst pain/anxiety possible, were compared in an ordinal logistic regression model. Women's anxiety increased significantly in the standard group (logit slope=0.18, p<0.001), did not change in the empathy group (slope=-0.04, p=0.45), and decreased significantly in the hypnosis group (slope=-0.27, p<0.001). Pain increased significantly in all three groups (logit slopes: standard care=0.53, empathy=0.37, hypnosis=0.34; all p<0.001) though less steeply with hypnosis and empathy than standard care (p=0.024 and p=0.018, respectively). Room time and cost were not significantly different in an univariate ANOVA despite hypnosis and empathy requiring an additional professional: 46 min/161 dollars for standard care, 43 min/163 dollars for empathy, and 39 min/152 dollars for hypnosis. We conclude that, while both structured empathy and hypnosis decrease procedural pain and anxiety, hypnosis provides more powerful anxiety relief without undue cost and thus appears attractive for outpatient pain management.

Diagnostic performance of digital versus film mammography for breast-cancer screening.

BACKGROUND: Film mammography has limited sensitivity for the detection of breast cancer in women with radiographically dense breasts. We assessed whether the use of digital mammography would avoid some of these limitations. METHODS: A total of 49,528 asymptomatic women presenting for screening mammography at 33 sites in the United States and Canada underwent both digital and film mammography. All relevant information was available for 42,760 of these women (86.3 percent). Mammograms were interpreted independently by two radiologists. Breast-cancer status was ascertained on the basis of a breast biopsy done within 15 months after study entry or a follow-up mammogram obtained at least 10 months after study entry. Receiver-operating-characteristic (ROC) analysis was used to evaluate the results. RESULTS: In the entire population, the diagnostic accuracy of digital and film mammography was similar (difference between methods in the area under the ROC curve, 0.03; 95 percent confidence interval, -0.02 to 0.08; P=0.18). However, the accuracy of digital mammography was significantly higher than that of film mammography among women under the age of 50 years (difference in the area under the curve, 0.15; 95 percent confidence interval, 0.05 to 0.25; P=0.002), women with heterogeneously dense or extremely dense breasts on mammography (difference, 0.11; 95 percent confidence interval, 0.04 to 0.18; P=0.003), and premenopausal or perimenopausal women (difference, 0.15; 95 percent confidence interval, 0.05 to 0.24; P=0.002). CONCLUSIONS: The overall diagnostic accuracy of digital and film mammography as a means of screening for breast cancer is similar, but digital mammography is more accurate in women under the age of 50 years, women with radiographically dense breasts, and premenopausal or perimenopausal women. (ClinicalTrials.gov number, NCT00008346.)

American College of Radiology Imaging Network digital mammographic imaging screening trial: objectives and methodology.

This study was approved by the Institutional Review Board (IRB) of the American College of Radiology Imaging Network (ACRIN) and each participating site and by the IRB and the Cancer Therapy Evaluation Program at the National Cancer Institute. The study was monitored by an independent Data Safety and Monitoring Board, which received interim analyses of data to ensure that the study would be terminated early if indicated by trends in the outcomes. The ACRIN, which is funded by the National Cancer Institute, conducted the Digital Mammographic Imaging Screening Trial (DMIST) primarily to compare the diagnostic accuracy of digital and screen-film mammography in asymptomatic women presenting for screening for breast cancer. Over the 25.5 months of enrollment, a total of 49 528 women were included at the 33 participating sites, which used five different types of digital mammography equipment. All participants underwent both screen-film and digital mammography. The digital and screen-film mammograms of each subject were independently interpreted by two radiologists. If findings of either examination were interpreted as abnormal, subsequent work-up occurred according to the recommendations of the interpreting radiologist. Breast cancer status was determined at biopsy or follow-up mammography 11-15 months after study entry. In addition to the measurement of diagnostic accuracy by using the interpretations of mammograms at the study sites, DMIST included evaluations of the relative cost-effectiveness and quality-of-life effects of digital versus screen-film mammography. Six separate reader studies using the de-identified archived DMIST mammograms will also assess the diagnostic accuracy of each of the individual digital mammography machines versus screen-film mammography machines, the effect of breast density on diagnostic accuracy of digital and screen-film mammography, and the effect of different rates of breast cancer on the diagnostic accuracy in a reader study.

Relaxation techniques for reducing pain and anxiety during screening mammography.

OBJECTIVE: The purpose of this study was to determine whether listening to a relaxation audiotape before and during mammography decreases subjective reports of pain and anxiety. CONCLUSION: Listening to a relaxation or music audiotape before and during mammography does not reduce subjective reports of anxiety or pain. Women undergoing screening mammography report minimal levels of distress.

Massachusetts radiology resident attitudes toward mammography.

PURPOSE: To investigate and document the attitudes toward careers in breast imaging among Massachusetts radiology residents. METHOD: Written surveys were distributed to all senior radiology residents in the state asking whether they were interested in pursuing a fellowship in breast imaging or whether they planned to interpret mammograms as part of their future practice. If they were not interested, residents were asked why. RESULTS: Of 63 residents who responded, only 1 was interested in a breast-imaging fellowship. Only 3% of radiology residents surveyed in the state agreed that they would like to spend a substantial time interpreting mammograms in the future. The most common reasons cited for not wanting to interpret mammograms in the future were "fear of lawsuits" (76%) and "not an interesting field" (49%). CONCLUSIONS: Very few Massachusetts radiology residents are interested in pursuing breast imaging in their future careers. This lack of interest in breast imaging will ultimately affect women's access to breast imaging services in the future.

Improvement in sensitivity of screening mammography with computer-aided detection: a multiinstitutional trial.

OBJECTIVE: Our study evaluated radiologist detection of breast cancer using a computer-aided detection system. MATERIALS AND METHODS: Three radiologists reviewed 377 screening mammograms interpreted as showing normal or benign findings 9-24 months before cancer diagnosis from 17 of the 18 participating centers. In 313 cases, study radiologists recommended additional mammographic evaluation. In 177 cases, the area warranting additional workup precisely correlated with the subsequently diagnosed cancer. These 177 missed cancers were evaluated with computer-aided detection. The proportion of radiologists identifying the missed cancers was used to determine radiologist sensitivity without computer-aided detection. RESULTS: The study radiologists determined that 123 of the 377 missed cancer cases warranted workup. Therefore, 123 additional cancers cases could have been found. The calculated radiologist sensitivity without computer-aided detection was therefore 75.4% (377 / [377 + 123]). Similarly, using the performance of the system on the missed cancers, we estimated that 80 (65.0%) of these 123 missed cancer cases would have been identified with the use of computer-aided detection. Consequently, the estimated sensitivity of radiologists using computer-aided detection was 91.4% ([377 + 80] / [377 + 123])-resulting in a 21.2% ([91.4% / 75.4%] - 1) increase in radiologist sensitivity with computer-aided detection. CONCLUSION: Use of the computer-aided detection system significantly improved the detection of breast cancer by increasing radiologist sensitivity by 21.2%. Therefore, for every 100,000 women with breast cancer identified without the use of computer-aided detection, an estimated additional 21,200 cancers would be found with the use of computer-aided detection.

Report of the Howard Hughes Medical Institute's workshop on the performance of laboratory chemical hoods.

The Howard Hughes Medical Institute sponsored a workshop on laboratory chemical hoods on June 8, 9, and 10, 1998, that brought together 24 experts in the field of laboratory chemical hoods to critically assess the information known about hood performance. Workshop participants developed 31 consensus statements that reflect their collective views on the body of knowledge or lack thereof, for laboratory chemical hoods. The consensus statements fall into four broad categories: (1) hood selection, use, and operation; (2) hood and laboratory design issues; (3) ventilation system design issues; and (4) hood performance testing. The consensus statements include 26 statements on what is known and unknown about the performance of laboratory chemical hoods, 2 statements of definition, and 3 statements that reflect the participants' agreement not to agree. The brief commentary that follows each consensus statement provides guidance and recommendations.

(99m)Tc sestamibi breast imaging for the examination of patients with dense and fatty breasts: multicenter study.

PURPOSE: To evaluate the accuracy of scintimammography as an adjunct to physical examination and mammography in the detection of breast cancer in women with dense and fatty breasts. MATERIALS AND METHODS: A total of 558 women were prospectively enrolled from 42 centers in North America. Images were interpreted by readers blinded to the subjects' clinical history, mammographic findings, and other test results. The Breast Imaging Reporting and Data System classification was used to describe breast density. Parenchymal patterns of "heterogeneously dense" and "extremely dense" were used to classify breasts as dense, whereas "almost entirely fat" and "numerous vague densities" defined fatty breasts. Between-group differences were evaluated with the 2 test for categorical variables and Student t test for continuous variables. Accuracy of scintimammography was assessed against the core laboratory histopathologic evaluation, the standard. The 95% CIs around point estimates of sensitivity, specificity, and positive and negative predictive values were calculated with the normal approximation to the binomial distribution. RESULTS: The analyses were based on 580 breasts with an abnormality; 276 (48%) breasts were dense and 228 had a malignant lesion. Diagnostic properties for scintimammography of fatty versus dense breasts were, respectively, sensitivity, 72% versus 70%; specificity, 80% versus 78%; positive predictive value, 72% versus 67%; negative predictive value, 81% versus 81%; and accuracy, 77% versus 75% (all not significant). Scintimammography led to similar and significant changes in the posttest likelihood of cancer for both dense and fatty breasts. CONCLUSION: The diagnostic accuracy of scintimammography is not affected by breast density.