Available online 30 August 2022, 101843

Supine MRI images were acquired at several hospital sites and transferred via a web-based process to a Radiologist who identified tumor edges on serial slices, providing surgeons with an interactive 3D view of the tumor in the breast.

A patient-specific plastic bra-like form, the Breast Cancer Locator, was used intra-operatively to place wires to bracket the supine MRI-defined tumor volume and facilitate accurate breast cancer resection.

This novel guidance system was used on 14 patients by 6 surgeons at 4 different sites. Use of this system resulted in no adverse events and margin negative resections in all patients.

Evaluate whether the Breast Cancer Locator™ (BCL), a novel guidance system based on supine MRI images, can be safely and effectively deployed by several surgeons at multiple sites.

Patients with palpable breast cancer underwent supine MRI at their local institution. A three dimensional (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.

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.

Supine MRI image acquisition was accomplished successfully across multiple sites. Multiple surgeons utilized the BCL system to localize cancers accurately and safely.

supine MRI

Breast conserving surgery

Breast cancer

Lumpectomy

Guidance

Device

© 2022 Published by Elsevier Ltd.