Assessing Improvement in Detection of Breast Cancer with Three-dimensional Automated Breast US in Women with Dense Breast Tissue: The SomoInsight Study

Published Online:https://doi.org/10.1148/radiol.14132832

The results of this study indicated that there is an increase in cancer detection with use of automated breast US supplemented to mammography among women with dense breasts, producing detection of an additional 1.9 cancers, most of which were clinically important, per 1000 women screened at the cost of a higher recall rate.

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.

© RSNA, 2014

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Article History

Received December 12, 2013; revision requested January 10, 2014; final revision received May 28; accepted June 12; final version accepted July 31.
Published online: Oct 17 2014
Published in print: Mar 2015