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 outcomes. Among the annual performance of >200,000 lumpectomies in the US, 25% of patients need reoperations, when post-surgery pathology examination reveals “positive margin”, indicating incomplete tumor removal. Currently physicians rely either on 2D intra-operative specimen imaging, which has only ~53% sensitivity for positive margin detection, or on randomly shaving additional tissues at all margins, leading to 50% higher excision volume and worse cosmetic outcome. We propose a VSI system that yields full-3D images of the specimen with isotropic, sub-100µm resolution, and workflow-streamlining software applications which can significantly improve margin assessment and enable precisely targeted shave margin. Uniquely enabled by a proprietary algorithm invented by Clarix founders, the VSI provides superior image quality meeting clinical requirements and drastic imaging acceleration for seamless workflow integration. In 4-5 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 <10% while reducing excision volume by 30%, thereby dramatically reducing healthcare costs and patient inconvenience while improving cosmetic outcomes. We have successfully achieved all the Aims in our Phase I study, which include (1) to verify that image-quality requirements can be met by a calibrated VSI prototype, (2) to verify that scan-time requirements can be met by optimizing VSI parameters, and (3) to verify that VSI has 85% sensitivity and 90% specificity for assessing lumpectomy margins. In our Phase II study, we hypothesize that an optimized VSI prototype can meet technical, workflow, and regulatory requirements for clinical application, and can result in substantially improved margin-assessment accuracy and breast-tissue conservation. The Specific Aims are: (1) to optimize VSI device for robust image acquisition in OR, (2) to create VSI software modules for seamless OR workflow integration, and (3) to conduct clinical VSI validation for enhancing margin-assessment accuracy and reducing shave-margin volume.