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.

抽象的 Clarix Imaging，Corporation（Clarix）致力于解决早期乳房中最大的问题之一 癌症治疗，正边缘的重新运作。约有200,000名患者中约有25％ 美国每年在美国的肿块切除术将面临此额外的程序，因为当前的选择 术中正缘不足。目前，医生依靠2D标本成像 评估手术期间的边缘状态，该状态无法充分代表3D边缘形态 瘤。因此，Clarix正在开发一种新型的体积标本成像仪VSI，可产生完全3D的设备 各向同性分辨率的样品图像，可以显着提高利润率评估和 在关闭伤口之前​​，为定向腔剃须提供精确的指导。在第一阶段，我们证明了 我们的VSI专利算法能够克服常规3D图像的长时间扫描时间 在一项20盘回顾性试点研究中，手术破坏了手术。在第二阶段，我们开发了一个强大的原型 为用户易于使用和安全而设计的硬件以及用于用户友好或工作流程的软件。 在大规模230患者回顾性中，将这种转移到制造现成的原型进一步验证 学习。第三阶段将在2019年第三季度提交的VSI设备的初始FDA 510（k）申请。 现在，我们提出了一个IIB期项目的四个具体目标，该项目将有助于克拉里克斯 技术开发和商业化如下。目标1，“开发软件以进一步改进 临床工作流程和放射科学图像数据库”将进一步简化领导 电子病历系统以及将开发数据库，​​该数据库将配对VSI数据和数字 病理记录。 AIM 2：“开发VSI设备的制造过程” AIM 3：“前瞻性II期临床试验”多中心单臂100患者临床试验将是 进行初步评估VSI设备将正余率降低到10％的能力。目的 4：“关键随机临床试验”这项600次患者III期试验将旨在确定确定 负边缘提高到90％，这表明了本研究中当前标准的优势 将允许对FDA进行特定的FDA批准，以进行保证金评估和广泛采用。美国6,000 在进行的运动下，激励了进行肿块切除术的医院和诊所进行肿块切除术 倾向于基于价值的报销，形成约7.2亿美元的美国初始安装基础。我们的全球市场是 估计约为$ 4B。在IIB期结束时，我们将在区域证明商业生存能力，然后证明 我们将在国内和国际上进行扩展。