An intraoperative breast cancer probe demonstrated potential for reducing positive surgical margins in lumpectomy patients—including those with hard-to-detect, pre invasive, ductal carcinoma in situ (DCIS)—according to two separate studies presented at the American Society of Breast Surgeons (ASBS) Annual Meeting. A cancer patient with positive margins typically requires a second surgery. The Dune Medical Devices (Caesarea, Israel) probe uses radio frequency spectroscopy to characterize breast tissue in real-time during surgery to determine margin malignancy status and holds promise to reduce re-excision procedures.
Selected for oral presentation at the 2007 ASBS conference, the first study found that the device fully detected 86 percent of positive margin patients during surgery, potentially converting them to negative status during this initial procedure. In the study, intact lumpectomy specimens were sampled immediately following excision by applying the Dune probe to multiple measurement sites on each margin examined. The probe readings were compared with post-operative pathology results on the same precisely identified margin areas. Conducted at two medical centers, the trial analyzed 314 breast tumor margins with approximately 3,600 measurement points.
The second study found that the Dune device was able to identify 20 out of 21 DCIS sites post-operatively on freshly excised breast cancer tissue as verified by pathology reports. It involved 46 lumpectomy specimens and 282 measurement sites, which were carefully selected to exclude tumor-concentrated sites. The Dune device also identified pathologies for a full range of additional breast tumor types with a complete or high degree accuracy.
According to lead study author Dr. Tami Karni of the Sackler School of Medicine, Tel Aviv University, Israel, and the Breast Care Institute, Assaf Harofe Medical Center, Israel, the primary objective of breast conservation surgery today is to achieve complete excision of tumors surrounded by a rim of pathology-free tissue.
“Today, no accurate method exists for determining margin malignancy status intraoperatively. The Dune device could spare a significant percentage of women additional surgeries by enabling highly accurate tissue classification while patients are still in the operating room and appropriate interventions can be made,” said Karni. “The Dune probe holds tremendous promise for enabling treatment of DCIS in a single surgery, minimizing cosmetic impact and physical and emotional trauma of follow-up procedures.”