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Radiology. 2015 Mar;274(3):663-73. doi: 10.1148/radiol.14132832. Epub 2014 Oct 17.

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

Author information

1
From the Breast Imaging and Interventional Center, George Washington University Medical Center, 2150 Pennsylvania Ave NW, Washington, DC 20037 (R.F.B., J.A.R., J.T.); Uppsala School of Medicine and Department of Mammography, Falun Central Hospital, Uppsala, Sweden (L.T.); Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, England (S.W.D.); Department of Pathology and Laboratory Medicine, University of Kansas Medical Center, Kansas City, Kan (M.F.I.); Department of Radiology, OSF Saint Francis Medical Center, Peoria, Ill (J.A.G.); Department of Radiology, Virginia Mason Medical Center, Seattle, Wash (B.E.H.); Department of Radiology, Desert Regional Comprehensive Cancer Center, Palm Springs, Calif (M.R.L.); Department of Radiology, Doctor's Hospital, Opelousas, La (R.L.L.); Radiology Regional Center, Fort Myers, Fla (M.K.P.); Carol Hatton Breast Care Center, Community Hospital of the Monterey Peninsula, Monterey, Calif (S.R.); Boca Radiology Group, Boca Raton Regional Hospital, Boca Raton, Fla (K.J.S.); Department of Radiology, Henry Ford Hospital, Detroit, Mich (B.A.S.); Department of Radiology, Columbia University Medical Center, New York, NY (R.T.W.); and ICON Clinical Research, San Francisco, Calif (D.P.M.).

Abstract

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.

PMID:
25329763
DOI:
10.1148/radiol.14132832
[Indexed for MEDLINE]

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