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.

项目概要 在此快速通道（第一阶段 + 第二阶段）SBIR 申请中，我们将评估准确的可行性（第一阶段）， 快速且低成本的仪器 (qF-ImageTM) 设计，可实现绝对浓度的精确宽视场成像 荧光团 PpIX (CPpIX) 在手术野中指导脑肿瘤切除的作用，并证明 设计满足临床验收所需的定量最终用户规格。在第二阶段，我们将最终确定 qF-ImageTM 设计在第一阶段确定，采用完整的设计控制质量管理体系 (QMS) 并按照行业法规，生产多达 5 个功能齐全的 qF-ImageTM 单元，验证最终结果 通过临床可用性和调查数据进行设计，并向 FDA 申请 510k 监管许可。 qF- ImageTM 概念是作为 NIH 资助（R01NS052274-10；PI：Roberts）荧光引导手术的一部分而出现的 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 Surgical Technologies (IST) 最近由该合作的高级成员创立，他们带来了 丰富的领域专业知识。商业化尤其及时：(i) ALA-PpIX 荧光引导 手术已获得 FDA 批准用于治疗高级别神经胶质瘤，(ii) 公司已采取重大行动 荧光引导手术表明了一个重要的全球市场（例如，Stryker 购买 NOVADAC 用于 2017 年约 7 亿美元，手术机器人市场领导者 Intuitive 纳入荧光检测 外科），(iii) 其他医疗科技公司（例如美敦力、蔡司）的兴趣很高，(iv) 广泛的临床 结果表明，定量 CPpIX 相对于定性和主观视觉具有令人信服的优势 (v) IST 是唯一一家追求定量广域商业化的企业 CPpIX 图像（该技术受 9 项已发布/正在申请的专利保护）。事实上，我们的研究级 仪器已应用于超过 150 名脑肿瘤患者：结果表明 PpIX 水平 商业系统（例如 Zeiss Blue 400）不可见的荧光可以用更大的 白光切除结束时检测残留病灶的灵敏度和特异性，使更多 完全切除肿瘤，包括低级别和高级别癌症。此外，qF-ImageTM 可以 进行修改以检测（i）其他荧光团，（ii）切除床下方深度的肿瘤，以及（iii）多个 同一情况下的荧光团——在未来产品中实现的功能。 InSight的商业计划 qF-ImageTM 将 qF-ImageTM 定位为市场上首款用于 CPpIX 宽视场成像的产品 – 绝对的 脑肿瘤中 PpIX 的浓度。