title: Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.).
authors.forename: Rachel F
authors.initials: RF
authors.lastname: Brem
authors.forename: László
authors.initials: L
authors.lastname: Tabár
authors.forename: Stephen W
authors.initials: SW
authors.lastname: Duffy
authors.forename: Marc F
authors.initials: MF
authors.lastname: Inciardi
authors.forename: Jessica A
authors.initials: JA
authors.lastname: Guingrich
authors.forename: Beverly E
authors.initials: BE
authors.lastname: Hashimoto
authors.forename: Marla R
authors.initials: MR
authors.lastname: Lander
authors.forename: Robert L
authors.initials: RL
authors.lastname: Lapidus
authors.forename: Mary Kay
authors.initials: MK
authors.lastname: Peterson
authors.forename: Jocelyn A
authors.initials: JA
authors.lastname: Rapelyea
authors.forename: Susan
authors.initials: S
authors.lastname: Roux
authors.forename: Kathy J
authors.initials: KJ
authors.lastname: Schilling
authors.forename: Biren A
authors.initials: BA
authors.lastname: Shah
authors.forename: Jessica
authors.initials: J
authors.lastname: Torrente
authors.forename: Ralph T
authors.initials: RT
authors.lastname: Wynn
authors.forename: Dave P
authors.initials: DP
authors.lastname: Miller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging*; D055088:Early Detection of Cancer / Q000592:standards*; D005260:Female; D006801:Humans; D021621:Imaging, Three-Dimensional; D008327:Mammography; D008875:Middle Aged; D058996:Quality Improvement; D016217:Ultrasonography, Mammary