Wendie A. Berg MD, PhD, Presenter: Consultant, Naviscan PET Systems, Inc Consultant, Siemens AG

Jeffrey D. Blume PhD, Abstract Co-Author: Nothing to Disclose

Jean B. Cormack PhD, Abstract Co-Author: Nothing to Disclose

Ellen Bachman Mendelson MD, Abstract Co-Author: Advisory Board, The Medipattern Corporation, Toronto, ON, Canada

Daniel E. Lehrer MD, Abstract Co-Author: Nothing to Disclose

Marcela Bohm-Velez MD, Abstract Co-Author: Nothing to Disclose

Etta D. Pisano MD, Abstract Co-Author: Institutional research agreement, General Electric Company

Roberta A. Jong MD, Abstract Co-Author: Research collaboration, General Electric Company

W. Phil Evans MD, Abstract Co-Author: Scientific Advisory Board, Hologic, Inc

Marilyn J. Morton DO, Abstract Co-Author: Nothing to Disclose

Mary C. Mahoney MD, Abstract Co-Author: Speakers Bureau, Johnson & Johnson (Ethicon Endo-Surgery, Inc), Cincinnati, OH

Linda Hovanessian-Larsen MD, Abstract Co-Author: Nothing to Disclose

Richard Gary Barr MD, PhD, Abstract Co-Author: Consultant, Siemens AG Consultant, Koninklijke Philips Electronics NV Grant, Bracco Group Grant, Bristol-Myers Squibb Company

Helga Marques MS, Abstract Co-Author: Nothing to Disclose

Karan Boparai RT, Abstract Co-Author: Nothing to Disclose

et al, Abstract Co-Author: Nothing to Disclose

et al, Abstract Co-Author: Nothing to Disclose

To compare the diagnostic yields of combined ultrasound and mammography screening to mammography alone.

2809 women at high-risk for breast cancer with nonfatty breasts were recruited from 21 IRB-approved sites to undergo mammography (M) or physician-performed ultrasound (US) exams in randomized in order, masked, and interpreted by different physicians prior to an integrated interpretation. Reference standard is based on biopsy and/or 12 month follow-up.

The 2504 eligible participants (with 4525 breasts on study) with complete data (mean age 55, range 25-91) were at high risk due to: 53% with personal history of breast cancer, 42% familial high risk by Gail or Claus models, 3% prior ADH/ALH/LCIS or atypical papilloma, 1% with BRCA mutations, and 1%, prior mediastinal/chest radiation therapy. Forty breasts in 39 patients (1 bilateral case) were diagnosed with cancer: 8 seen on both US and M, 12 on US alone, 12 on M alone, and 8 on neither. Yield for M alone was 8 per 1000 women screened (20/2504) and for combined US+M was 12.4 per 1000 (31/2504), resulting in a supplemental yield of 4.4 per 1000 women screened (95% CI 1.2 to 7.6 per 1000; p=0.003 that yield is zero). Diagnostic accuracy (AUC) for M was 0.79 (95% CI 0.68 to 0.88) versus US+M AUC of 0.93 (95% CI 0.86 to 0.97, p= 0.004). One 4 mm invasive cancer seen on M was considered probably benign after integration with US. The 12 supplemental cancers seen only by US were DCIS (1), IDC+DCIS (7), ILC (1), and mixed IDC/ILC (3). Mean size of invasive cancers seen only on US was 12 mm (range 5 to 40 mm) and 9/10 (90%) reported had negative nodes. In the 35% of breasts (1586) evaluated with digital M, 14 cancers were diagnosed: 3 seen on both US and M, 4 on US alone, 3 only on M, and 4 on neither. Relative breast density did not affect supplemental US yield. There were 5 interval cancers, including one melanoma metastatic to axillary nodes.

Addition of screening US to mammography increases the diagnostic accuracy of screening and depicts an additional 1.2 to 7.6 cancers per 1000 high-risk women screened.

Detection of mammographically-occult early stage breast cancer is improved with supplemental US screening. Support from the Avon Foundation and National Cancer Institute (CA80098)

Berg, W, Blume, J, Cormack, J, Mendelson, E, Lehrer, D, Bohm-Velez, M, Pisano, E, Jong, R, Evans, W, Morton, M, Mahoney, M, Hovanessian-Larsen, L, Barr, R, Marques, H, Boparai, K, et al, , et al, , Yield of Screening Breast Ultrasound and Mammography Compared to Mammography Alone: Results of First Screen in ACRIN (American College of Radiology Imaging Network).  Radiological Society of North America 2007 Scientific Assembly and Annual Meeting, November 25 - November 30, 2007 ,Chicago IL. http://archive.rsna.org/2007/5002923.html