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 investigate the rates of recall, biopsy, and short interval follow-up and rates of malignancy for each, when mammography is supplemented by screening ultrasound in high-risk women.

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 order, masked, and interpreted by different physicians prior to an integrated interpretation (US+M). Reference standard is based on biopsy and/or 12 month follow-up.

There were 2504 eligible participants (with 4525 breasts on study) with complete data (mean age 55, range 25-91). Of these, 13% of M screening exams were recommended for other than routine follow-up, as were 28% of combined M+US screening exams (p<0.001, 95% CI for difference = 13.5 to 16.7%). After combined M+US, this resulted in 702 recommendations at the participant level: 266 for 6 month follow-up (206 prompted only by US), 195 for additional imaging (14 prompted only by US), and 241 for biopsy (199 prompted only by US). After completing additional evaluation, including imaging at the time of planned biopsy, 259 (10%) participants actually had biopsy (46 based only on mammography, 168 based only on US and 45 based on both). Of 168 (6.7%) participants recommended for biopsy based only on US, 12 (7.1%) proved to have cancer, 6 (3.6%) atypical lesions, and 150 (89%) benign results; of 46 participants biopsied based only on mammography, 12 (26%) had cancer, 1 atypical lesion (2%), and 33 (72%) benign results. Of 274 participants initially followed, only 1 (0.7%) proved to have malignancy within 12 month follow-up; this was a 4 mm invasive cancer seen on initial screening M, followed after integration with US, with metastatic nodes at diagnosis.

Addition of US screening to mammography resulted in additional biopsies in 6.7% (95% CI, 5.7-7.8%) of participants, of whom only 7.1% (95% CI, 3.7-12.1%) proved to have cancer. Additional short-interval follow-up was prompted in another 8% of participants based solely on US.

There is a substantial risk of false positives when screening US is added to mammography in high-risk women. 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, , Risk of False Positives with Supplemental Screening Breast US: Results from the First Screen in the 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/2007/5005381.html