Wide-Field Quantitative Fluorescence Imaging System

广域定量荧光成像系统

• 批准号: 10687286
• 负责人: DAVID W ROBERTS
• 金额: $ 101.26万
• 依托单位: INSIGHT SURGICAL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-07 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10687286
• 关键词: Beds; Biomedical Engineering; Brain Neoplasms; Breast; Businesses; Clinical; Clinical Data; Collaborations; Data; Detection; Devices; Diagnostic; Disease; Excision; FDA approved; Feedback; Fluorescein; Fluorescence; Fluorescent Probes; Foundations; Freezing; Funding; Future; Glioma; Goals; Hand; Image; Imaging technology; Industry; Intellectual Property; Intracranial Neoplasms; Intuition; Legal patent; Light; Lung; Malignant Neoplasms; Maps; Mediation; Medical; Medical Device; Morbidity - disease rate; Multi-site clinical study; Operative Surgical Procedures; Optics; Patients; Performance; Phase; Positioning Attribute; Production; Regulation; Research; Resectable; Residual Tumors; Residual state; Rights; Risk; Robotics; Sensitivity and Specificity; Series; Site; Small Business Innovation Research Grant; Software Design; Specimen; Strategic Planning; Surface; Surgeon; Surgical Oncology; Surveys; System; Technology; Testing; Time; United States National Institutes of Health; Validation; Visual; base; blind; brain tumor resection; commercialization; cost; design; fluorescence imaging; fluorescence-guided surgery; fluorophore; image processing; imaging system; improved outcome; innovation; insight; instrument; interest; meetings; member; minimally invasive; product development; prototype; tumor; usability

PROJECT SUMMARY In this Fast Track (Phase I + Phase II) SBIR application, we will evaluate feasibility (in Phase I) of an accurate, fast and low-cost instrument (qF-ImageTM) design for accurate wide-field imaging of the absolute concentration of the fluorophore PpIX (CPpIX) in the surgical field for guiding brain tumor resection, and demonstrate that design meets quantitative end-user specifications required for clinical acceptance. In Phase II, we will finalize the qF-ImageTM design identified in Phase I under a full quality management system (QMS) for design-control and in compliance with industry regulations, produce up to 5 fully functional qF-ImageTM units, validate the final design through clinical usability and survey data, and apply to FDA for 510k regulatory clearance. The qF- ImageTM concept arose as part of NIH-funding (R01NS052274-10; PI: Roberts) in fluorescence-guided surgery involving biomedical engineering/optics and neurosurgical research teams at Dartmouth and Toronto. InSight Surgical Technologies (IST) was founded recently by the senior members of this collaboration who bring substantial domain expertise. Commercialization is particularly timely: (i) ALA-PpIX fluorescence-guided surgery has been FDA-approved for high-grade glioma, (ii) substantial corporate moves have occurred in fluorescence-guided surgery indicating a significant global market (e.g., Stryker purchase of NOVADAC for ~$700M in 2017, and incorporation of fluorescence detection by a market leader in surgical robotics, Intuitive Surgical.), (iii) interest from other MedTech companies (e.g., Medtronic, Zeiss) is high, (iv) extensive clinical results demonstrate compelling advantages of quantitative CPpIX over qualitative and subjective visual fluorescence imaging, and (v) IST is the only venture pursuing commercialization of quantitative wide-field CPpIX images (the technology is protected by 9 issued/pending patents). Indeed, our research-grade instrument has been deployed in >150 brain tumor patients: results demonstrate that levels of PpIX fluorescence not visible with commercial systems (e.g., Zeiss Blue 400) can be quantified with greater sensitivity and specificity for detection of residual disease at end of white-light resection, enabling more complete tumor removal, including in low-grade as well as high-grade cancers. Additionally, qF-ImageTM can be modified to detect (i) other fluorophores, (ii) tumor at depth below the resection bed, and (iii) multiple fluorophores in the same case – capabilities to be implemented in future products. InSight’s business plan positions qF-ImageTM as the first product on the market for wide-field imaging of CPpIX – the absolute concentration of PpIX in brain tumor.

项目摘要 在此快速轨道（I期 +阶段II阶段）应用程序中，我们将评估准确的（在I期中）的可行性， 快速和低成本仪器（QF-imagetm）设计，用于绝对浓度的准确宽视野成像 手术区域中的荧光团PPIX（CPPIX）用于指导脑肿瘤，并证明这一点 设计满足临床接受所需的定量最终用户规格。在第二阶段，我们将最终确定 I阶段的QF-imagetm设计在I阶段的全质量管理系统（QMS）下，用于设计控制 并符合行业法规，最多生产5个功能齐全的QF-Imagetm单位，验证最终 通过临床可用性和调查数据设计，并适用于FDA进行510K监管清除率。 QF- Imagetm概念作为NIH资金的一部分（R01NS052274-10； PI：Roberts）的一部分 涉及达特茅斯和多伦多的生物医学工程/光学和神经外科研究团队。洞察力 该合作的高级成员最近建立了手术技术（IST） 实质领域的专业知识。商业化特别及时：（i）ALA-PPIX荧光引导 手术已被FDA批准用于高级神经胶质瘤，（ii）（ii）发生了实质性的公司移动 荧光引导的手术表明全球大量市场（例如，斯特赖克（Stryker 2017年〜7亿美元，并通过外科机器人技术领域的市场领导者合并了荧光检测 外科手术。 结果表明，定量CPPIX比定性和主观视觉的优势令人信服 荧光成像，（v）IST是唯一追求定量广场商业化的冒险 CPPIX图像（该技术受9条发布/申请专利保护）。确实，我们的研究级 仪器已在> 150名脑肿瘤患者中部署：结果表明PPIX水平 可以通过更大的量化商业系统（例如，蔡司蓝色400）可见的荧光（例如蔡司蓝色400） 在白光切除结束时检测残留疾病的敏感性和特异性，使得更多 完全去除肿瘤，包括低级和高级癌症。另外，QF-Imagetm可以 修改以检测（i）其他荧光团，（ii）切除床以下深度的肿瘤，（iii）多重 在同一情况下的荧光团 - 将来产品中要实现的功能。 Insight的业务计划 位置QF-Imagetm是CPPIX市场上的第一个市场上的第一个产品 - 绝对 脑肿瘤中PPIX的浓度。