title: Automated Breast Ultrasound in Breast Cancer Screening of Women With Dense Breasts: Reader Study of Mammography-Negative and Mammography-Positive Cancers.
abstract: OBJECTIVE
  The objective of our study was to assess and compare, in a reader study, radiologists' performance in the detection of breast cancer using full-field digital mammography (FFDM) alone and using FFDM with 3D automated breast ultrasound (ABUS).
  
  
  METHODS
  In this multireader, multicase, sequential-design reader study, 17 Mammography Quality Standards Act-qualified radiologists interpreted a cancer-enriched set of FFDM and ABUS examinations. All imaging studies were of asymptomatic women with BI-RADS C or D breast density. Readers first interpreted FFDM alone and subsequently interpreted FFDM combined with ABUS. The analysis included 185 cases: 133 noncancers and 52 biopsy-proven cancers. Of the 52 cancer cases, the screening FFDM images were interpreted as showing BI-RADS 1 or 2 findings in 31 cases and BI-RADS 0 findings in 21 cases. For the cases interpreted as BI-RADS 0, a forced BI-RADS score was also given. Reader performance was compared in terms of AUC under the ROC curve, sensitivity, and specificity.
  
  
  RESULTS
  The AUC was 0.72 for FFDM alone and 0.82 for FFDM combined with ABUS, yielding a statistically significant 14% relative improvement in AUC (i.e., change in AUC = 0.10 [95% CI, 0.07-0.14]; p < 0.001). When a cutpoint of BI-RADS 3 was used, the sensitivity across all readers was 57.5% for FFDM alone and 74.1% for FFDM with ABUS, yielding a statistically significant increase in sensitivity (p < 0.001) (relative increase = 29%). Overall specificity was 78.1% for FFDM alone and 76.1% for FFDM with ABUS (p = 0.496). For only the mammography-negative cancers, the average AUC was 0.60 for FFDM alone and 0.75 for FFDM with ABUS, yielding a statistically significant 25% relative improvement in AUC with the addition of ABUS (p < 0.001).
  
  
  CONCLUSIONS
  Combining mammography with ABUS, compared with mammography alone, significantly improved readers' detection of breast cancers in women with dense breast tissue without substantially affecting specificity.
authors.affiliation: 1 Department of Radiology, University of Chicago, 5841 S Maryland Ave, MC 2026, Chicago, IL 60637.
authors.forename: Maryellen L
authors.initials: ML
authors.lastname: Giger
authors.affiliation: 2 University of Kansas Medical Center, Kansas City, KS.
authors.forename: Marc F
authors.initials: MF
authors.lastname: Inciardi
authors.affiliation: 1 Department of Radiology, University of Chicago, 5841 S Maryland Ave, MC 2026, Chicago, IL 60637.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Edwards
authors.affiliation: 1 Department of Radiology, University of Chicago, 5841 S Maryland Ave, MC 2026, Chicago, IL 60637.
authors.forename: John
authors.initials: J
authors.lastname: Papaioannou
authors.affiliation: 1 Department of Radiology, University of Chicago, 5841 S Maryland Ave, MC 2026, Chicago, IL 60637.
authors.forename: Karen
authors.initials: K
authors.lastname: Drukker
authors.affiliation: 1 Department of Radiology, University of Chicago, 5841 S Maryland Ave, MC 2026, Chicago, IL 60637.
authors.forename: Yulei
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: 3 Department of Radiology, George Washington University, Washington, DC.
authors.forename: Rachel
authors.initials: R
authors.lastname: Brem
authors.affiliation: 1 Department of Radiology, University of Chicago, 5841 S Maryland Ave, MC 2026, Chicago, IL 60637.
authors.forename: Jeremy Bancroft
authors.initials: JB
authors.lastname: Brown
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging*; D002277:Carcinoma / Q000000981:diagnostic imaging*; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008327:Mammography; D008875:Middle Aged; D011237:Predictive Value of Tests; D012372:ROC Curve; D012189:Retrospective Studies; D016217:Ultrasonography, Mammary; D055815:Young Adult
keywords: breast imaging; screening; ultrasound; whole-breast ultrasound