A pilot multi-institutional study to evaluate the accuracy of a supine MRI based guidance system, the Breast Cancer LocatorTM, in patients with breast cancer

Background: Evaluate whether the Breast Cancer LocatorTM (BCL), a novel guidance system based on supine MRI images, can be safely and effectively deployed by several surgeons at multiple sites. Methods: Patients with palpable breast cancer underwent supine MRI at their local institution. A three dimen-sional (3D) digital image of the tumor in the breast was derived from supine MRI images and used to generate 1) an interactive 3D virtual image of the tumor in the breast (Visualizer) and 2) a plastic bra-like form that allowed the surgeon to place a central wire and bracketing wires in the breast (BCL). The primary objective was to determine the proportion of patients who had the central localization wire deployed within the cancer on specimen mammogram.Results: Fourteen patients were enrolled at 4 different sites by 6 surgeons. BCLs were successfully manufactured for all patients. The central wire was deployed within the tumor on specimen mammogram in 12 of the 13 patients who had a central wire placed (92%). The cancer was excised with negative margins in 14/14 cases (100%). No adverse events occurred.Conclusions: Supine MRI image acquisition was accomplished successfully across multiple sites. Multiple surgeons utilized the BCL system to localize cancers accurately and safely.