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

项目摘要 Clarix图像(CI)是一家从芝加哥大学(UC)剥离出来的初创医疗设备公司 一种实时X射线体积样品成像仪(VSI)设备和软件解决方案，可实现准确和 手术室(OR)和病理实验室的快速3D边际评估(MA)。我们建议使用SBIR 第一阶段研究以确定基于VSI的软件平台的可行性，以实现多学科 肿块切除评估工作流，这为优化创新的、用户友好的 具有优化的MA准确性和效率的工作流程，适用于常规临床应用。一年一度的 在美国，20万例门诊乳房肿块切除术的再手术率很高(25%)。与此同时，没有肿瘤是 在这些再手术中，高达63%被发现，导致同时过度治疗不必要的健康 组织和未接受治疗的肿瘤可能残留在患者的乳房内。这个问题的一个主要原因是 外科医生、放射科医生和病理学家之间对标本定位的高度不一致是由于缺乏 充分的工具促进他们在现有的并购工作流程中的协作。目前的做法依赖于 外科医生的缝合线、标本X线片和病理学家的墨水以定位阳性切缘(PM)。研究 显示外科医生、放射科医生和病理学家对PM位置的不符合率在以下范围内 31%对52%。还有一种未得到满足的需求，即改进工作流程，以在 多学科团队。最近，CI开发了用于实时全三维肿瘤切除标本的VSI设备 在手术室做影像检查。VSI的可用性为创新的软件平台和 可为肿块切除术评估启用更好的多学科工作流程的应用程序。它的产物是 SBIR将是一个软件平台，允许实时、远程共享可视化和注解完整的3D VSI 由多个用户创建的图像。该软件还将使外科医生能够通过虚拟墨水来传达精确的 整个多学科团队的样本定位。我们预计在未来3-4年内推出 建议的软件平台作为标准的临床工作流程，与VSI设备一起，他们 完成肿块切除术MA的CI解决方案。第一阶段项目的具体目标是(1)创建和 验证用于共享多用户VSI数据可视化的软件平台，以及(2)创建和验证 支持优化MA工作流程的虚拟墨迹应用程序。实现这些目标将牢固地确立 使用建议的基于VSI的软件平台实现优化的多领域并购的可行性 工作流程，降低二期工作的技术风险，包括(1)优化软件平台 医院网络环境下的网络安全和健壮性，(2)全面开发虚拟墨迹 将技术优化集成到临床工作流集成中，以及(3)实施临床工作流 对患者样本进行验证，并为FDA提交做准备。做肿块切除术的6000名外科医生 美国的9000家病理实验室都在使用过时的基于缝合的工作流程，并准备采用我们的 软件，代表着每年约1.5亿个潜在的市场机会。我们计划将VSI设备引入 顾客至上。它将作为软件产品的催化剂，该软件产品将与VSI捆绑提供 或者作为一项单独的增值服务。

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.