Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study.

PURPOSE: To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts. MATERIALS AND METHODS: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study. The SomoInsight Study was an observational, multicenter study conducted between 2009 and 2011. A total of 15 318 women (mean age, 53.3 years ± 10 [standard deviation]; range, 25-94 years) presenting for screening mammography alone with heterogeneously (50%-75%) or extremely (>75%) dense breasts were included, regardless of further risk characterization, and were followed up for 1 year. Participants underwent screening mammography alone followed by an AB US examination; results were interpreted sequentially. McNemar test was used to assess differences in cancer detection. RESULTS: Breast cancer was diagnosed at screening in 112 women: 82 with screening mammography and an additional 30 with AB US. Addition of AB US to screening mammography yielded an additional 1.9 detected cancers per 1000 women screened (95% confidence interval [CI]: 1.2, 2.7; P < .001). Of cancers detected with screening mammography, 62.2% (51 of 82) were invasive versus 93.3% (28 of 30) of additional cancers detected with AB US (P = .001). Of the 82 cancers detected with either screening mammography alone or the combined read, 17 were detected with screening mammography alone. Of these, 64.7% (11 of 17) were ductal carcinoma in situ versus 6.7% (two of 30) of cancers detected with AB US alone. Sensitivity for the combined read increased by 26.7% (95% CI: 18.3%, 35.1%); the increase in the recall rate per 1000 women screened was 284.9 (95% CI: 278.0, 292.2; P < .001). CONCLUSION: Addition of AB US to screening mammography in a generalizable cohort of women with dense breasts increased the cancer detection yield of clinically important cancers, but it also increased the number of false-positive results.

Reduction of discomfort during mammography utilizing a radiolucent cushioning pad.

The purpose of this study was to evaluate the use of a radiolucent cushioning pad during routine screening mammography to determine the degree of reduction in discomfort, any correlation of that reduction with various clinical factors, and the pad's impact on image quality, compression force, and radiation dose. A total of 512 patients presenting for routine screening mammography were evaluated. The radiolucent cushioning pads (MammoPad, Biolucent Inc., Aliso Viejo, CA) were placed on the bucky and compression paddle of the mammographic equipment (M-IV, Lorad Corp., Danbury, CT). For each patient, the radiolucent pads were used for imaging one breast while the opposite breast, which served as a control, was imaged without the pads. In all patients, the breast was positioned and compressed in standard fashion, using routine craniocaudal (CC) and mediolateral oblique (MLO) views. Patients completed a questionnaire before and after the mammogram. A visual analog scale (VAS) was used to record anticipated discomfort as well as the discomfort experienced during compression with and without the pads. Age, hormone replacement status, prior experience with mammography, compression force, and breast composition were recorded, as were dose parameters (mAs and kVp), from which midglandular dose values were calculated. On the side where the pads were used to cushion the breast, 73.5% (371/505) of women experienced a significant decrease in discomfort. Of those who benefited, there was a 47% decrease in discomfort. On the pad side, compression force was increased an average of 14%, and there was a 4% decrease in dose for the CC view and no increase in dose for the MLO view. When comparing benefit versus nonbenefit groups, a significant reduction in discomfort did not correlate with any of the clinical factors evaluated, with the exception of experienced discomfort reported after the mammogram. Use of the MammoPad radiolucent cushion on the bucky and compression paddle was an effective means of reducing discomfort during compression for a majority (73.5%) of our patients undergoing screening mammography. Image quality and the ability to detect all pertinent anatomy were maintained.