MarginProbeA© reduces the rate of re-excision following breast conserving surgery for breast cancer

A positive margin status after breast conserving surgery (BCS) is one of the strongest predictors for local recurrence of intraductal (DCIS) and invasive carcinoma. As much as 20-50 % of patients with BCS need to undergo a second operation to receive free margins. In this study we tested the clinical performance of MarginProbeA (c) (Dune Medical Devices, Paoli, PA, USA), a device for the intraoperative evaluation of surgical margins. A prospective clinical study was performed: The device was utilized in BCS of 150 patients treated at a single facility from November 2012 to June 2013. The re-excision rate was compared to the re-excision rate of a historical group of 172 patients treated with BCS at the same hospital without the application of the device. We analyzed whether the results of MarginProbeA (c) are affected by the morphology, grading, size of the tumor, breast density, age, BMI or the use of marker-wires. The application of MarginProbeA (c) resulted in an overall decreased re-excision rate of 14.6 %. In the subgroup of DCIS the re-excision rate was reduced from 61.7 to 23.1 %. In the subgroup of invasive lobular carcinomas the re-excision rate decreased from 37.0 to 19.0 %. MarginProbeA (c) results were not affected by grading, tumor size, breast density, age, BMI or marker-wire application. MarginProbeA (c) detects positive margins in invasive carcinoma, DCIS as well as in invasive lobular carcinoma. The device decreases the re-excision rate after BCS significantly. It does not interfere with any of the factors we examined.