A novel intraoperative breast cancer probe developed in Israel is showing significant promise in the reduction of repeat procedures in patients undergoing breast-conserving surgeries, according to a study presented at the American Society of Breast Surgeons Annual Scientific Meeting.
Using radiofrequency spectroscopy technology, the handheld MarginProbe (Dune Medical Devices, Caesarea, Israel) assesses margin malignancy status in real time during an initial lumpectomy and helps avoid repeat procedures by enabling doctors to intraoperatively identify positive margins and shave additional tissue.
The 300-patient randomized clinical trial was conducted at 11 Israeli medical centers. All patients were undergoing breast-conserving surgery. The study compared the ability of 35 surgeons to detect tumors at the resection margins with and without use of the device.
“In the device group, the surgeon applied the probe to the excised lumpectomy specimen, sampling 5 to 12 points per margin, and shaving additional tissue according to device readings,” said Tanir
Allweis, MD, of Hadassah Hebrew University Medical Center, Jerusalem, an investigator in the study who presented the results.
Number of repeat surgeries reduced
Use of the probe resulted in a 56% reduction in repeat lumpectomies (5.6% vs 12.7%, P = .0027). There was no significant difference between the two study arms in the volume of tissue removed or cosmetic outcome. In a subset of 173 patients with nonpalpable lesions, repeat surgery rates, including mastectomy, were 9.8% vs 20.9% (P = .02) for device and control arms, respectively, a 53% reduction.
The radiofrequency spectroscopy device includes a sterile, handheld probe and a portable console. As the tip of the probe is applied to excised lumpectomy tissue, radiofrequency signals are transmitted into the tissue.
After the signals are reflected back to the console, they are analyzed based on a specialized algorithm to determine the presence of malignant tissue in the measured area adjacent to the probe tip.