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

用于 3D 术中肿瘤切除术边缘评估的实时体积标本成像仪

• 批准号: 10208795
• 负责人: Xiao Han
• 金额: $ 146.01万
• 依托单位: CLARIX IMAGING CORPORATION
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10208795
• 关键词: 3-Dimensional; Address; Adopted; Adoption; Algorithmic Software; Algorithms; Breast; Breast Cancer Treatment; Clinical; Clinical Research; Clinical Trials; Clinics and Hospitals; Computer software; Computerized Medical Record; Cosmetics; Data; Databases; Devices; Diagnostic radiologic examination; Excision; Face; Goals; Hand; Hospital Information Systems; Hospitals; Image; Imaging Device; Incentives; International; Intervention Trial; Left; Legal patent; Malignant Neoplasms; Mammary Gland Parenchyma; Mammography; Masks; Mastectomy; Morphology; Movement; Operating Rooms; Operative Surgical Procedures; Outcome; Outpatients; Palpation; Pathology; Patients; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Physicians; Pilot Projects; Plant Roots; Procedures; Radiology Specialty; Randomized Clinical Trials; Records; Regulation; Repeat Surgery; Resolution; Retrospective Studies; Roentgen Rays; Safety; Scanning; Sensitivity and Specificity; Small Business Innovation Research Grant; Specimen; Surgeon; System; Techniques; Technology; Three-Dimensional Image; Time; Tissues; Validation; Woman; arm; base; breast lumpectomy; commercial application; commercialization; cost; design; digital pathology; efficacy study; experience; imager; improved; improved outcome; malignant breast neoplasm; manufacturing process; manufacturing process development; mortality; novel; novel strategies; operation; pathology imaging; phase III trial; prospective; prototype; software development; standard of care; success; targeted imaging; technology development; tumor; user friendly software; wound

Abstract Clarix Imaging, Corporation (Clarix) is focused on solving one of the largest problems in early stage breast cancer treatment, reoperations for positive margins. About 25% of the >200,000 patients who undergo lumpectomy in the US each year will face this additional procedure because current options for identifying positive margins intraoperatively are insufficient. Currently physicians rely on 2D specimen imaging for assessing margin status during surgery which cannot adequately represent the 3D margin morphology of the tumor. Therefore, Clarix is developing a novel volumetric specimen imager, VSI, device that yields fully 3D images of the specimen with isotropic resolution which can significantly improve margin assessment and provide precise guidance for directed cavity shaves before closing wound. In Phase I, we demonstrated the ability of our VSI patented algorithms to overcome long scan times of conventional 3D imagers that would disrupt surgical in a 20-case retrospective pilot study. In Phase II, we developed a robust prototype with hardware designed for user ease of use and safety, and software for user-friendly OR workflow integration. This transfer to manufacturing ready prototype was further validated in a large-scale 230 patient retrospective study. An initial FDA 510(k) application for the VSI device resulting from Phase II will be submitted in Q3 2019. We now propose four specific aims for a Phase IIB project that will help Clarix bridge the gap between technology development and commercialization as follows. Aim 1, “Develop Software for Further Improved Clinical Workflow and Radiology-Pathology Image Database” will further streamline integration into leading Electronic Medical Record systems, and a database will be developed which will pair VSI data and digital pathology records. Aim 2: “Develop Manufacturing Process for the VSI Device” for large scale manufacturing ability. Aim 3: “Prospective Phase II Clinical Trial” a multi-center single-arm 100 patient clinical trial will be conducted to preliminarily evaluate the ability of the VSI device to decrease positive margin rates to 10%. Aim 4: “Pivotal Randomized Clinical Trial” this 600 patient Phase III trial will be designed to definitively determine improvement in negative margins to 90%, demonstration of superiority over the current standard in this study will allow for specific FDA approval of FDA for margin assessment and widespread adoption. The 6,000 US hospitals and clinics performing lumpectomy are incentivized to adopt VSI under the ongoing movement toward value-based reimbursement, forming a ~$720M initial US installed-base. Our global market is estimated at ~$4B. At the conclusion of Phase IIB we will prove the commercial viability regionally, and then we will scale nationally and internationally.

摘要