CairnSurgical Breast Cancer Locator Trial Begins

BCL 3D printed form

The first patient has been treated in a U.S. pivotal trial of CairnSurgical’s Breast Cancer Locator (BCL) System. The system is designed to eliminate guesswork in breast cancer surgery by providing a blueprint of the tumor and a surgical guide to achieve clear margins.

Background

Current Breast Conserving Surgery (BCS) is unsuccessful at removing the entire tumor about 20 percent of the time. This is primarily because current tumor localization techniques do not provide the information required to achieve precise removal of the disease.

According to a recent study on breast cancer tumor shapes, less than 20 percent are spherical in shape. This makes techniques that place implants or wires in one or two central points within the tumor of limited to no value in identifying its size, boundaries and margins.

CairnSurgical, Inc., is a clinical stage medical device company developing patient-specific surgical guides using patient imaging data and state-of-the-art 3D printing technologies. The company’s BCL System is designed to reduce positive margin rates, and to enables precise tumor localization and excision.

The procedure involves creation of a 3D printed form, the BCL, using MRI. The BCL fits the unique shape of the patient’s breast, with ports for several central and bracketing wires to be placed under anesthesia in the operating room immediately prior to surgery. The wires guide the surgeon to the tumor boundaries and margins. An interactive 3D image – the Visualizer – is provided to the surgeon. This information provides valuable references for the surgeon during the procedure

The BCL has been tested in both single arm and randomized clinical trials. In a study of published in the Annals of Surgical Oncology, clear tumor margins were achieved in all 19 patients. A multicenter pilot study of the BCL System currently underway has continued to demonstrate clear tumor margins in every patient.

The BCL Study is a prospective, multicenter, 1:1 randomized, controlled pivotal trial of breast cancer excision surgery in 448 women with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS) tumors treated at up to 15 U.S. centers. Patients will be randomized to either the BCL or standard wire localization to guide surgery. The primary endpoint is positive margin rate, with other endpoints being specimen volumes, rate of additional shave biopsies, re-excision rate, cancer localization rate, operative time and cost of care.

Clinician comments

“We are committed to participating in clinical research with the potential to improve outcomes for our patients with breast cancer,” said Suzanne Coopey, MD, Massachusetts General Hospital, who performed the first BCL case.

“We are very interested in evaluating whether this new approach to guiding the surgeon to tumor margins can make breast cancer surgery more accurate and reduce the need for additional surgery for positive margins.”

Investigator comments

Jennifer Gass, MD, Principal Investigator of the BCL study, Chief of Surgery, Women & Infants Hospital, and Professor of Surgery, Obstetrics and Gynecology, The Warren Alpert Medical School of Brown University, said, “We are very excited to be pursuing this clinical study and this new approach to breast cancer surgery because patients deserve our best efforts to improve clinical outcomes in BCS. We hope this tool will allow us to tailor the surgical resection to the best representation of the patient’s own tumor. We have assembled a diverse group of study sites to evaluate the BCL in multiple settings, and look forward to comparing the ability of the technology to affect positive tumor margin, excision volume, and re-excision when compared to standard wire localization.”

Source: CairnSurgical, Inc.

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