A device for real-time, intraoperative margin assessment in breast-conservation surgery

Abstract 

Background

This trial was designed to study performance of a novel handheld probe (Dune Medical Devices, Caesarea, Israel) in intraoperative detection of positive margins and its potential benefit toward minimizing the positive margin rate.

Methods

The probe was intraoperatively applied to 57 lumpectomy specimens. Surgeons were blinded to device output, and surgical decisions were not affected by probe data. Probe readings were compared with histological analysis per margin and per patient.

Results

Nineteen of 22 (86%) pathology-positive patients were intraoperatively detected with device use. Per-margin sensitivity was .71, and specificity was .68, maintained within a range of positive margin definitions (0–.4 cm).

Conclusions

The device is an effective tool for intraoperative detection of positive margins with the potential for significant positive margin rate reduction.

Keywords: Breast cancer, Breast-conservation surgery, Intraoperative margin assessment, Surgical margins, Lumpectomy