A Volumetric-Imaging Software Platform for Enabling Optimized Workflow of Multidisciplinary Lumpectomy Assessment

项目总结

Project Summary Clarix Imaging (CI) is a startup medical device company spun out of The University of Chicago (UC) to develop a real-time X-ray volumetric specimen imager (VSI) device and software solution for enabling accurate and rapid 3D margin assessment (MA) in the operating room (OR) and pathology laboratory. We propose this SBIR Phase I research to establish the feasibility of a VSI-based software platform for enabling multidisciplinary workflows for lumpectomy assessment, which lays the foundation for optimizing an innovative, user-friendly workflow with optimized MA accuracy and efficiency for routine clinical application. The annual performance of >200,000 outpatient breast lumpectomies in the US has a high reoperation rate (25%). Meanwhile, no tumor is found in up to 63% of these reoperations, resulting in simultaneous over-treatment of unnecessary healthy tissues and under-treatment as tumor may remain in the patient’s breast. A leading cause of this problem is the high discordance among surgeons, radiologists, and pathologists on specimen orientation due to the lack of adequate tools facilitating their collaboration in the existing MA workflow. The current practice relies on surgeon’s sutures, specimen radiographs, and pathologist’s inking to localize positive margin (PM). Studies showed that the discordance rate on PM location among surgeons, radiologists, and pathologists range from 31% to 52%. There is an unmet need for an improved workflow yielding better agreement among the multidisciplinary team. Recently, CI developed the VSI device for real-time full 3D lumpectomy specimen imaging in the OR. The availability of VSI provides the foundation for innovative software platform and applications that can enable better multidisciplinary workflows for lumpectomy assessment. The product of this SBIR will be a software platform that allows real-time, remote shared visualization and annotation of full 3D VSI images by multiple users. The software will also enable virtual inking by the surgeon to communicate a precise specimen orientation across the entire multidisciplinary team. We envision in the next 3-4 years to introduce the proposed software platform as the standard clinical workflow, and together with the VSI device, they complete the CI solution for lumpectomy MA. The Specific Aims of the Phase I project are (1) to create and validate the software platform for shared multi-user visualization of VSI data, and (2) to create and verify the virtual inking application for enabling optimized MA workflow. Reaching these Aims will firmly establish the feasibility of using the proposed VSI-based software platform to enable optimized multidisciplinary MA workflow, and reduce the technical risk of Phase II work, which includes (1) optimizing the software platform cybersecurity and robustness within a hospital network environment, (2) fully developing the virtual inking technique optimally integrated in the clinical workflow integration, and (3) conducting clinical workflow validation with patient specimens and prepare for FDA submission. The 6,000 ORs performing lumpectomies and 9,000 pathology labs in the US are all using dated suture-based workflows and are ready to adopt our software, representing ~150M annual addressable market opportunity. We plan to introduce the VSI device to customers first. It will serve as a catalyst for the software product, which will be offered either bundled with VSI or as a separate, value-added service.