Wendie A. Berg MD, PhD, Presenter: Consultant, Naviscan, Inc

Zheng Zhang PhD, Abstract Co-Author: Nothing to Disclose

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

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

Marcela Böhm-Vélez MD, Abstract Co-Author: Nothing to Disclose

Etta D. Pisano MD, Abstract Co-Author: Institutional research agreement, General Electric Company Institutional contract, Konica Minolta Group Institutional contract, VuCOMP, Inc Institutional contract, Real Imaging Institutional contract, Sectra AB

Roberta A. Jong MD, Abstract Co-Author: Research Consultant, 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: Consultant, Johnson & Johnson Speakers Bureau, Johnson & Johnson Consultant, SenoRx, Inc Speakers Bureau, SenoRx, Inc Scientific Advisory Board, Hologic, Inc

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 Research grant, Siemens AG

Dione Marie Farria MD, Abstract Co-Author: Nothing to Disclose

Ellen Bachman Mendelson MD, Abstract Co-Author: Medical Advisory Board, Hologic, Inc Speaker, The Medipattern Corporation, Toronto, ON Scientific Advisory Board, Siemens AG Research support, Supersonic Imagine, Aix-en-Provence, FR Equipment support, Koninklijke Philips Electronics NV Speaker, Toshiba Corporation

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

Amanda Adams MPH, Abstract Co-Author: Nothing to Disclose

Glenna Gabrielli BS, Abstract Co-Author: Nothing to Disclose

00030490-DMT et al, Abstract Co-Author: Nothing to Disclose

To investigate rates of recall, biopsy, and short interval follow-up and rates of malignancy for each, when annual screening ultrasound (US) is added to mammography in women at elevated risk of breast cancer.

2809 women at elevated risk for breast cancer with nonfatty breasts were recruited 4/04 to 2/06 from 21 IRB-approved sites to undergo mammography (M) and physician-performed US exams, randomized in order, masked, and interpreted by different physicians prior to integrated interpretation, with screening at time 0 (year 1), 12 (year 2), and 24 months (year 3). Reference standard is based on biopsy and/or 12-month follow-up for each screen. PPV1 (cancers/cases recalled for additional imaging) and PPV2 (cancers/biopsies recommended after workup) were calculated.

2648 participants had reference standard for year 1; 2487 for year 2; and 1921 for year 3. In year 1, 20 cancers were identified on M and 31 after M+US, with PPV1 = 7.2% (20/279) for M and 6.9% (31/448) for M+US and PPV2 = 22% (19/87) for M and 10.7% (31/289) for M+US. In year 2, 16 cancers were identified on M and 25 after M+US, with PPV1 = 6.2% (16/260) for M and 6.7% (25/373) for M+US and PPV2 = 25% (15/61) for M and 13.0% (24/184) for M+US. One cancer was followed or dismissed in each of years 1 and 2 after workup. In year 3, 23 cancers were identified on M and 31 after M+US, with PPV1 = 13.1% (23/175) for M and 11.5% (31/270) for M+US and PPV2 = 40% (23/57) for M and 19.5% (31/159) for M+US. Short interval follow-up was recommended as follows: year 1, 109/2648 (4.1%) on M and 336 (12.7%) after M+US; year 2, 59/2487 (2.4%) on M and 139 (5.6%) after M+US; and year 3, 29/1921 (1.5%) on M and 87 (4.5%) after M+US. Of 197 participants recommended for short-interval follow-up on M, 1 (0.5%) was diagnosed with cancer before the next screen, compared to 4/562 (0.7%) after M+US.

Annual US resulted in additional biopsy recommendation in 225/4408 (5.1%) screens in years 2 and 3 and only 17/225 (7.6%) proved to have cancer; PPV1 and PPV2 of M+US did increase in year 3 compared to the prevalence screen. Additional short-interval follow-up was prompted in 138/4408 (3.1%) incidence screens based on US. [Support from The Avon Foundation and National Cancer Institute (CA079778, CA80098).]

False positive biopsies remain problematic for screening US even on subsequent screening rounds. Rates of short interval follow-up prompted by US decreased on incidence vs. prevalence screens.

Berg, W, Zhang, Z, Marques, H, Lehrer, D, Böhm-Vélez, M, Pisano, E, Jong, R, Evans, W, Morton, M, Mahoney, M, Hovanessian-Larsen, L, Barr, R, Farria, D, Mendelson, E, Cormack, J, Adams, A, Gabrielli, G, et al, 0, False Positives Induced by Annual Screening US Added to Mammography: ACRIN *6666* American College of Radiology Imaging Network.  Radiological Society of North America 2009 Scientific Assembly and Annual Meeting, November 29 - December 4, 2009 ,Chicago IL. http://archive.rsna.org/2009/8003363.html