Katrin Hegenscheid MD, Presenter: Nothing to Disclose

Birger Mensel MD, Abstract Co-Author: Nothing to Disclose

Rene Laqua, Abstract Co-Author: Nothing to Disclose

Robin Bülow MD, Abstract Co-Author: Nothing to Disclose

Norbert Hosten MD, Abstract Co-Author: Nothing to Disclose

Ralf Puls MD, Abstract Co-Author: Nothing to Disclose

Currently, scant data exist on the prevalence and the handling of incidental findings (IFs) in imaging research. The German population-based Study of Health in Pomerania (SHIP) is the first study that implemented a whole-body Magnetic Resonance Imaging (wb-MRI) protocol in a general population cohort. We developed a protocol for the management of IFs in wb-MRI providing prevalence data of clinically relevant IFs.

SHIP is IRB approved and all subjects gave written informed consent. In 2008-2012, 3652 out of 5654 subjects (64.6%) from SHIP agreed to participate in wb-MRI. After exclusion of 360 (9.9%) volunteers a total of 3292 subjects (1667 women, 1625 men; mean age, 53 years) underwent standardized wb-MRI. Additionally, 1490 participants received contrast-enhanced cardiac MRI, 814 men received MR angiography, and 732 women received MR mammography. Two independent radiologists performed first-line reading. A third reader resolved disagreements. During a staged reading and decision process including an interdisciplinary advisory board, IFs were classified into three basic categories: IFs normal or common in asymptomatic subjects (category I), IFs needing further medical evaluation (category II), IFs requiring immediate referral (category III). Category II and III IFs were disclosed.

Out of 17,717 findings detected, there were 1610 IFs of potential clinical relevance in 1131 (34.4%) subjects. Eleven findings (0.7%) required immediate referral (category III). 1343 (83.4%) findings were confirmed by the advisory board and disclosed to 997 (30.3%) participants (category II). Most disclosed findings, 1115 (83.0%), resulted from plain wb-MRI. The genital system (female; 19.5%, male; 11.0%), the urinary tract (15.6%), the abdominal organs (14.9%), and the skeletal system (13.7%) were affected most often. Complex renal cysts and tumors (N=133, 4.0%) were the most prevalent IF on plain wb-MRI. In men, prostatic hyperplasia (N=124, 7.6%) and in women, breast lesions ≥ BI-RADS 3 (N=138, 18.9%) were the most prevalent IFs.

IFs of clinical relevance are very common in wb-MRI research. This requires a dedicated management to protect subjects’ welfare and research integrity.

Incidental findings are a largely neglected problem in human subjects research. This study provides the first prevalence data of clinically relevant findings from wb-MRI in a general population.

Hegenscheid, K, Mensel, B, Laqua, R, Bülow, R, Hosten, N, Puls, R, Prevalence and Management of Incidental Findings detected during Whole-Body MRI in the General Population.  Radiological Society of North America 2012 Scientific Assembly and Annual Meeting, November 25 - November 30, 2012 ,Chicago IL. http://archive.rsna.org/2012/12025331.html