Cairn Surgical reports positive results from a multicenter European post-market study of the Breast Cancer Locator (BCL) system. The aim was to remove tumors with negative resection margins in breast-conserving procedures (lumpectomy). In the November issue of Annals of Surgical Oncology, the author teams report a success rate of 94%: 31 out of 33 patients were operated on with negative margins, while two cases showed positive margins in invasive lobular cancer and DCIS, respectively.
“The goals of breast conserving surgery are to resect the cancer with negative margins and with an optimal cosmetic result. In this study, the BCL System enabled surgeons to perform precise breast conserving surgery, with margin-negative resections obtained in the vast majority of cases. They also achieved relatively low resected specimen volumes with high patient satisfaction,” said Prof. Dr. med. Marc Thill, Chief of Gynecology and Gynecologic Cancer at Agaplesion Markus Krankenhaus, Frankfurt, Germany, and clinical investigator in the study. “Investigators also universally found the system easy to use. They particularly appreciated the Visualizer tool, which allows us to interactively view the tumor in 3D and in the supine position, prior to and during surgery.”
Technically, the system consists of two components based on a supine MRI. From the imaging, a patient-specific, 3D-printed form—the actual locator—is produced, which conforms to the breast contour and intraoperatively marks tumor margins along with a defined safety margin. In parallel, software (“Visualizer”) renders the tumor volume in three dimensions in the operative position. Both components are used together during the procedure. According to the study, no additional shave margins were required to achieve negative margins; the mean specimen volume was 54 ml. No serious adverse events were observed. In surveys, 91% of surgeons were satisfied with the locator and 100% with the Visualizer.
The cohort included five centers in Germany, Switzerland, and Italy; 21% of cases involved invasive lobular carcinoma.
“It is clear that this novel approach, which provides the surgeon with far greater detail about a patient’s breast tumor, has the potential to dramatically improve the outcomes of breast conserving surgery,” said Richard Barth, Jr., MD, Dartmouth-Hitchcock Medical Center, Professor of Surgery, Geisel School of Medicine at Dartmouth, and Co-founder of Cairn Surgical. “The 6% positive margin rate demonstrated in this study is a 70% improvement compared to the 20% positive margin rate historically reported with wire localization in patients with non-palpable tumors.”
To further build evidence, a randomized, prospective pivotal study with up to 448 participants at up to 25 centers is underway, evaluating endpoints including positive margins, specimen volume, re-excisions, localization success, and operative time.
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