Magnetic resonance imaging system for intraoperative margin assessment for DCIS and invasive breast cancer using the ClearSightTM system in breast‐conserving surgery—Results from a postmarketing study

2023 - Marc Thill, Iris Szwarcfiter, Katharina Kelling, Viviane van Haasteren, Eyal Kolka, Josefa Noelke, Zachi Pees, Moshe Papa, Sebastian Aulmann, Tanir Allweis


Background and objectives: Breast‐conserving surgery (BCS) is followed by re- operations in approximately 25%. Reoperations lead to an increased risk of infection and wound healing problems as well as a worse cosmetic outcome. Several technical approaches for an intraoperative margin assessment to decrease the reoperation rate are under evaluation, some of them are still experimental.

Study results

The ClearSightTM system was performed for both ductal and lobular breast cancer and DCIS, with a sensitivity of 0.80 (95% confidence interval [CI]: 0.44–0.96) and a specificity of 0.84 (95% CI 0.72–0.92), with an overall diag- nostic accuracy of 80%.


Had the ClearSightTM been known to the surgeon intraoperatively, the reoperation rate would have been reduced by 83% for invasive carcinoma, from 10% to 2%, and 50% for DCIS, from 30% to 15% reoperations. A trial designed to examine the impact on reoperation rates is currently ongoing.