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

用于优化多学科肿瘤切除评估工作流程的体积成像软件平台

• 批准号: 10011691
• 负责人: Christian Wietholt
• 金额: $ 22.5万
• 依托单位: CLARIX IMAGING CORPORATION
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10011691
• 关键词: 3-Dimensional; Address; Adopted; Agreement; Breast; Chicago; Client; Clinical; Collaborations; Color; Communication; Computer software; Data; Devices; Environment; Foundations; Goals; Histology; Hospitals; Image; Imaging Device; Ink; Laboratories; Left; Legal patent; Location; Malignant Neoplasms; Market Research; Medical Device; Operating Rooms; Operative Surgical Procedures; Outpatients; Pathologist; Pathology; Patients; Performance; Phase; Positioning Attribute; Postoperative Period; Repeat Surgery; Reporting; Research; Residual Tumors; Risk; Roentgen Rays; Services; Slide; Small Business Innovation Research Grant; Software Validation; Specialist; Specimen; Surgeon; Surgical sutures; Techniques; Technology; Telephone; Thinness; Three-Dimensional Image; Three-Dimensional Imaging; Time; Tissues; Universities; Validation; Visualization; Woman; Work; base; breast lumpectomy; catalyst; clinical application; commercial application; cost; cyber security; design; imager; imaging software; improved; innovation; malignant breast neoplasm; multidisciplinary; operation; overtreatment; radiologist; sharing platform; three-dimensional visualization; tool; tumor; unnecessary treatment; user-friendly; virtual

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.

项目摘要 Clarix Imaging（CI）是一家从芝加哥大学（UC）分拆出来的初创医疗设备公司， 实时X射线体积样本成像仪（VSI）设备和软件解决方案， 在手术室（OR）和病理实验室进行快速3D边缘评估（MA）。我们提出这个SBIR 第一阶段研究，以确定基于VSI的软件平台的可行性， 乳房肿瘤切除术评估的工作流程，为优化创新的、用户友好的 优化MA准确性和效率的工作流程，适用于常规临床应用。全年业绩 在美国，超过200，000例门诊乳房肿块切除术的再手术率很高（25%）。与此同时， 在高达63%的再次手术中发现，导致同时过度治疗不必要的健康 组织和治疗不足，因为肿瘤可能留在患者的乳房中。这个问题的主要原因是 外科医生、放射科医生和病理科医生之间关于标本方向的高度不一致， 适当的工具，促进他们在现有的MA工作流程中的合作。目前的做法依赖于 外科医生的缝合线、标本X光片和病理学家的墨迹以定位阳性边缘（PM）。研究 结果显示，外科医生、放射科医生和病理科医生之间PM位置的不一致率从 31%到52%。有一个未得到满足的需要，即需要改进工作流程，以便在工作人员之间达成更好的协议。 多学科团队。最近，CI开发了用于实时全3D乳房肿瘤切除术标本的VSI设备 手术室里的影像VSI的可用性为创新的软件平台和 这些应用程序可以为乳房肿瘤切除术评估提供更好的多学科工作流程。这个产品 SBIR将是一个软件平台，允许实时、远程共享可视化和完整3D VSI注释 多个用户的图片。该软件还将使外科医生能够虚拟着墨，以传达精确的信息。 在整个多学科团队中进行标本定向。我们设想在未来3-4年内， 建议的软件平台作为标准临床工作流程，与VSI器械一起， 完成乳房肿瘤切除术MA的CI溶液。第一阶段项目的具体目标是（1）创建和 验证VSI数据共享多用户可视化的软件平台，以及（2）创建和验证 虚拟墨水应用程序，用于实现优化的MA工作流程。实现这些目标将坚定地建立 使用拟议的基于VSI的软件平台实现优化的多学科MA的可行性 工作流程，降低二期工作的技术风险，其中包括（1）优化软件平台 医院网络环境中的网络安全性和鲁棒性，（2）充分开发虚拟墨水 技术最佳地集成在临床工作流程集成中，以及（3）进行临床工作流程 使用患者样本进行验证，并准备向FDA提交。6,000个手术室在做乳房肿瘤切除术 在美国，9,000个病理学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，代表每年约1.5亿的潜在市场机会。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 或者作为单独的增值服务。