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.
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.
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.
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.
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.
The purpose of this study was to assess the performance of a MicroDose photon-counting full-field digital mammography (PCM) system in comparison to full-field digital mammography (FFDM) for area ...under the receiver-operating characteristic (ROC) curve (AUC), sensitivity, specificity, and feature analysis of standard-view mammography for women presenting for screening mammography, diagnostic mammography, or breast biopsy.
A total of 133 women were enrolled in this study at two European medical centers, with 67 women who had a pre-existing 10-36 months FFDM enrolled prospectively into the study and 66 women who underwent breast biopsy and had screening PCM and diagnostic FFDM, including standard craniocaudal and mediolateral oblique views of the breast with the lesion, enrolled retrospectively. The case mix consisted of 49 cancers, 17 biopsy-benign cases, and 67 normal cases. Sixteen radiologists participated in the reader study and interpreted all 133 cases in both conditions, separated by washout period of ≥4 weeks. ROC curve and free-response ROC curve analyses were performed for noninferiority of PCM compared to FFDM using a noninferiority margin Δ value of 0.10. Feature analysis of the 66 cases with lesions was conducted with all 16 readers at the conclusion of the blinded reads. Mean glandular dose was recorded for all cases.
The AUC for PCM was 0.947 (95% confidence interval CI, 0.920-0.974) and for FFDM was 0.931 (95% CI, 0.898-0.964). Sensitivity per case for PCM was 0.936 (95% CI, 0.897-0.976) and for FFDM was 0.908 (95% CI, 0.856-0.960). Specificity per case for PCM was 0.764 (95% CI, 0.688-0.841) and for FFDM was 0.749 (95% CI, 0.668-0.830). Free-response ROC curve figures of merit were 0.920 (95% CI, 0.881-0.959) and 0.903 (95% CI, 0.858-0.948) for PCM and FFDM, respectively. Sensitivity per lesion was 0.903 (95% CI, 0.846-0.960) and 0.883 (95% CI, 0.823-0.944) for PCM and FFDM, respectively. The average false-positive marks per image of noncancer cases were 0.265 (95% CI, 0.171-0.359) and 0.281 (95% CI, 0.188-0.374) for PCM and FFDM, respectively. Noninferiority P values for AUC, sensitivity (per case and per lesion), specificity, and average false-positive marks per image were all statistically significant (P < .001). The noninferiority P value for free-response ROC was <.025, from the 95% CI for the difference. Feature analysis resulted in PCM being preferred to FFDM by the readers for ≥70% of the cases. The average mean glandular dose for PCM was 0.74 mGy (95% CI, 0.722-0.759 mGy) and for FFDM was 1.23 mGy (95% CI, 1.199-1.262 mGy).
In this study, radiologist performance with PCM was not inferior to that with conventional FFDM at an average 40% lower mean glandular dose.
Abstract Breast tomosynthesis, a three-dimensional x-ray based breast imaging technology, has been available for clinical use in the United States since 2011. In this paper we review the literature ...on breast cancer screening with this new technology including where gaps in knowledge remain.
To determine the diagnostic accuracy of ultrasonographically (US) and stereotactically guided fine-needle aspiration biopsy (FNAB) in the diagnosis of nonpalpable breast lesions.
At 18 institutions, ...442 women who underwent 22-25-gauge imaging-guided FNAB were enrolled. Definitive surgical, core-needle biopsy, and/or follow-up information was available for 423 (95.7%) of these women. The reference standard was established from additional clinical and imaging information for an additional six (1.4%) women who did not undergo further histopathologic evaluation. The FNAB protocol was standardized at all institutions, and all specimens were reread by one of two expert cytopathologists.
When insufficient samples were included in the analysis and classified as positive, the sensitivity and specificity of FNAB were 85%-88% and 55.6%-90.5%, respectively; accuracy ranged from 62.2% to 89.2%. The diagnostic accuracy of FNAB was significantly better for detection of masses than for detection of calcifications (67.3% vs. 53.8%, P =.006) and with US guidance than with stereotactic guidance (77.2% vs. 58.9%; P =.002).
FNAB of nonpalpable breast lesions has limited value given the high insufficient sample rate and greater diagnostic accuracy of other interventions, including core-needle biopsy and needle-localized open surgical biopsy.
Background: Increased mammographic density reduces the sensitivity of screening mammography, is associated with increased breast cancer risk, and may be hormone related. We assessed the effect of ...estrogen-plus-progestin therapy on mammographic density. Methods: In a racially and ethnically diverse ancillary study of the Women's Health Initiative, we examined data from 413 postmenopausal women who had been randomly assigned to receive daily combined conjugated equine estrogens (0.625 mg) plus medroxyprogesterone acetate (i.e., progestin; 2.5 mg) (n = 202) or daily placebo (n = 211). We assessed the effect of estrogen plus progestin on measured mammographic percent density and abnormal findings over a 1-year and 2-year period. All tests of statistical significance were two-sided and were based on F tests or t tests from mixed-effects models. Results: Mean mammographic percent density increased by 6.0% at year 1, compared with baseline, in the estrogen-plus-progestin group but decreased by 0.9% in the placebo group (difference = 6.9%, 95% confidence interval CI = 5.3% to 8.5%; P<.001). The mean changes in mammographic density persisted but were attenuated slightly after 2 years, with an absolute increase of 4.9% in the estrogen-plus-progestin group and a decrease of 0.8% in the placebo group (difference = 5.7%, 95% CI = 4.3% to 7.3%; P<.001). These effects were consistent across racial/ethnic groups but were higher among women aged 70–79 years in the estrogen-plus-progestin group (mean increase at year 1 = 11.6%) than in the placebo group (mean decrease at year 1 = 0.1%) (difference of the means = 11.7%, 95% CI = 8.2% to 15.4%; P<.001, comparing across age groups). At year 1, women who were adherent to treatment in the estrogen-plus-progestin group had a mean increase in density of 7.7% (95% CI = 5.9% to 9.5%), and women in the placebo group had a mean decrease in density of 1.1% (95% CI = 0.3% to 1.9%). Use of estrogen plus progestin was associated with an increased risk of having an abnormal mammogram at year 1 (relative risk = 3.9, 95% CI = 1.5 to 10.2; P = .003), compared with placebo, that was not explained by an increase in density. Conclusions: Use of up to 2 years of estrogen plus progestin was associated with increases in mammographic density.
In this article, the published literature on the role of screening mammography in the detection of ductal carcinoma in situ (DCIS) is reviewed. This includes what is known about the detection of DCIS ...in different demographic groups. Finally the author describes her views on how the field might be advanced.
The purpose of this study was to determine whether there are identifiable factors that dissuade female medical students from entering the field of radiology.
An anonymous survey was completed by ...medical students at the end of their third- or fourth-year radiology clinical clerkships at five institutions. In addition to demographic data and residency choice, respondents ranked 10 factors in order of importance to their choice of career. For respondents who did not consider radiology a possible career, a second set of eight factors was ranked for importance in dissuading them.
Two hundred eighty-eight respondents completed the survey, 152 (53%) men and 136 (47%) women. Both men and women reported direct patient contact and intellectual stimulation as the most important factors in deciding on a specialty. For those who chose radiology, intellectual stimulation and use of emerging technology were significantly (p < 0.05) more important than other factors. The factor that most strongly (96%) dissuaded men and women from a career in radiology was lack of direct patient contact. There was no significant difference between men and women in ranking factors that dissuaded them from applying to radiology residencies; however, nearly one third of the female respondents cited competitiveness of the residency process as important.
Patient contact remains an important factor for medical students choosing a career. To attract high-caliber students, medical schools should expose students to areas of radiology involving patient interaction. Academically qualified women should be identified early during their careers and encouraged to apply for radiology residencies.
To retrospectively compare the accuracy for cancer diagnosis of digital mammography with soft-copy interpretation with that of screen-film mammography for each digital equipment manufacturer, by ...using results of biopsy and follow-up as the reference standard.
The primary HIPAA-compliant Digital Mammographic Imaging Screening Trial (DMIST) was approved by the institutional review board of each study site, and informed consent was obtained. The approvals and consent included use of data for future HIPAA-compliant retrospective research. The American College of Radiology Imaging Network DMIST collected screening mammography studies performed by using both digital and screen-film mammography in 49 528 women (mean age, 54.6 years; range, 19-92 years). Digital mammography systems from four manufacturers (Fischer, Fuji, GE, and Hologic) were used. For each digital manufacturer, a cancer-enriched reader set of women screened with both digital and screen-film mammography in DMIST was constructed. Each reader set contained all cancer-containing studies known for each digital manufacturer at the time of reader set selection, together with a subset of negative and benign studies. For each reader set, six or 12 experienced radiologists attended two randomly ordered reading sessions 6 weeks apart. Each radiologist identified suspicious findings and rated suspicion of breast cancer in identified lesions by using a seven-point scale. Results were analyzed according to digital manufacturer by using areas under the receiver operating characteristic curve (AUCs), sensitivity, and specificity for soft-copy digital and screen-film mammography. Results for Hologic digital are not presented owing to the fact that few cancer cases were available. The implemented design provided 80% power to detect average AUC differences of 0.09, 0.08, and 0.06 for Fischer, Fuji, and GE, respectively.
No significant difference in AUC, sensitivity, or specificity was found between Fischer, Fuji, and GE soft-copy digital and screen-film mammography. Large reader variations occurred with each modality.
No statistically significant differences were found between soft-copy digital and screen-film mammography for Fischer, Fuji, and GE digital mammography equipment.
PDF
