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

基本信息

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
项目类别：
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

项目摘要

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) 致力于解决早期乳腺的最大问题之一癌症治疗、切缘阳性的再次手术，在超过 200,000 名患者中约有 25% 接受过此类手术。在美国，每年的肿瘤切除术都会面临这种额外的手术，因为目前的选择目前，医生依靠 2D 标本成像来确定术中切缘阳性是不够的。评估手术期间无法充分代表 3D 边缘形态的边缘状态因此，Clarix 正在开发一种新型体积标本成像仪 VSI，该设备可产生完全 3D 图像。具有各向同性分辨率的样本图像，可以显着改善边缘评估和在闭合伤口之前为定向腔体剃须提供精确指导在第一阶段，我们展示了我们的 VSI 专利算法能够克服传统 3D 成像仪扫描时间长的问题在一项 20 例回顾性试点研究中，我们开发了一个强大的原型。为用户易用性和安全性而设计的硬件，以及为用户友好的手术室工作流程集成而设计的软件。这种向可制造原型的转移在 230 名患者的大规模回顾中得到了进一步验证 II 期研究产生的 VSI 设备的初始 FDA 510(k) 申请将于 2019 年第三季度提交。我们现在为 IIB 阶段项目提出四个具体目标，这将帮助 Clarix 弥合两者之间的差距技术开发和商业化目标 1，“开发软件以进一步改进”。临床工作流程和放射病理学图像数据库”将进一步简化与领先的集成将开发电子病历系统和数据库，将 VSI 数据与数字化配对目标 2：“开发 VSI 设备的制造工艺”以进行大规模制造。目标3：“前瞻性II期临床试验”将是一项多中心、单臂100名患者的临床试验。旨在初步评估 VSI 设备将正保证金率降低至 10% 的能力。 4：“关键随机临床试验”这项 600 名患者参加的 III 期试验旨在最终确定负裕度改善至 90%，证明优于本研究中的当前标准将允许 FDA 对利润评估进行特定批准并在 6,000 个美国广泛采用。在正在进行的运动中，鼓励进行肿瘤切除术的医院和诊所采用 VSI 基于价值的报销，形成了约 7.2 亿美元的美国初始安装基础。估计约为 4B 美元，在 IIB 阶段结束时，我们将证明区域性的商业可行性，然后我们将在国内和国际上扩大规模。