Wide-Field Quantitative Fluorescence Imaging System

广域定量荧光成像系统

基本信息

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
项目类别：
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

项目摘要

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) 在手术视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。 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。 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，由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荧光成像，以及 (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）。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 qF-ImageTM 还可以完全切除肿瘤，包括低级别和高级别癌症。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）多个同一案例中的荧光团——将在 InSight 的未来产品中实施的功能。 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。