CairnSurgical LLC, a Dartmouth spin-off company, will optimize and test the feasibility of a new image- guided intervention device, the Breast Cancer Locator (BCL), in breast conserving surgery (BCS) to (i) eliminate wire localization - a moderately effective, somewhat costly and certainly inconvenient procedure for patients - and concomitantly to (ii) reduce positive margin rates and subsequent re-excision surgeries - a significant but unnecessary burden not only on patients but also on the cost of healthcare. Specifically, BCL is a patient-specific, 3D printed device that allows accurate clinical transfer of multiple surgical cues not available through other competing technologies currently available, including i) a tumor silhouette projected on the breast surface as viewed from the incision site, ii) an intra-operatively placed wire that defines a direct path to the tumor from the incision site, iii) interstitial inking of the maximum tumor extents using an innovative system of access ports, and 4) distances from the anterior tumor edge to breast surface and the posterior tumor edge to the chest wall. In the proposed Phase 1 studies, CainSurgical will collaborate with Dartmouth clinicians and researchers to 1) develop and validate BCL model creation software, 2) optimize BCL manufacturing and sterilization processes, and 3) test the feasibility of BCL in surgical cases of 10 patients with palpable breast cancer. The positive margin rates associated with contemporary BCS are high (~22%-42%)9-13, and currently represent significant strains on patients and the cost of breast healthcare. Meta-analysis of the impact of surgical margins on local recurrence also confirms that margin status has a positive prognostic effect. Thus, CairnSurgical is well-positioned to explore and commercially develop a potentially practice-changing approach to BCS for accurate resection of breast cancers.
A surgical guidance device, Breast Cancer Locator (BCL), is proposed for improving accuracy of cancer resection during breast conserving surgeries (BCS). In this project CairnSurgical will develop and validate BCL software, manufacturing and sterilization processes and test its feasibility in a 10-patient clinical trial.