Real-time volumetric specimen imager for 3D intra-operative lumpectomy margin assessment

We propose to develop a novel volumetric specimen imager (VSI) system for significantly reducing breast lumpectomy’s reoperation rate and improving cosmetic outcomes. Among the annual performance of about 200,000 lumpectomies in the US, 15-25% of patients need reoperations, when post-surgery pathology examination reveals “positive margin”, indicating incomplete tumor removal in initial surgery. Currently surgeons rely on 2D intra-operative specimen imaging, which has only ~53% sensitivity for positive margin detection. We propose a robust VSI system that yields fully-3D images of the specimen with isotropic, sub-100µm resolution, and workflow-streamlining software applications which can significantly improve margin assessment and enable precisely image-guided shave margin. Uniquely enabled by a proprietary algorithm invented by Clarix founders, the VSI provides superior image quality meeting clinical requirements and significant imaging acceleration for seamless workflow integration. In 3-5 years, we plan to introduce the VSI-based solution as the new standard of care for lumpectomy, which is expected to lower the reoperation rate to under 10% while reducing excision volume by 30%, thereby considerably reducing healthcare costs and patient inconvenience while improving cosmetic outcomes. We have successfully achieved all Aims in Phase II study. In our Phase IIB study, we propose to (1) develop software for further integrated clinical workflow, (2) develop manufacturing process for the VSI device, and (3) perform a randomized, controlled multi-center trial.