Phase II: Fluorescence guided surgery standardization tools

第二阶段：荧光引导手术标准化工具

• 批准号: 10484198
• 负责人: Ethan Phillip Marshall LaRochelle
• 金额: $ 99.91万
• 依托单位: QUEL IMAGING LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484198
• 关键词: 3D Print; Accounting; Adopted; Adoption; Advocate; Affect; Blood Vessels; Calibration; Clinical; Clinical Trials; Collaborations; Development; Disease; Ensure; FDA approved; Feedback; Fluorescence; Future; Generations; Genotype; Geometry; Growth; Image; Image Analysis; Indocyanine Green; Industry; Ink; Investigation; Isosulfan Blue; Letters; Light; Medical; Medicine; Methods; Methylene blue; Modeling; Monitor; Online Systems; Operative Surgical Procedures; Optics; Paper; Pathway interactions; Performance; Perfusion; Phase; Photobleaching; Plant Resins; Positioning Attribute; Printing; Procedures; Production; Property; Protocols documentation; Publishing; Recommendation; Reporting; Resolution; Running; Services; Signal Transduction; Sodium Fluorescein; Standardization; Surface; Surgeon; Surgical Specialties; System; Techniques; Technology; Testing; Time; Tissues; Tracer; Translating; Vendor; Work; absorption; base; career networking; contrast enhanced; cost; cost effective; design; experience; fluorescence imaging; fluorescence-guided surgery; fluorophore; imaging facilities; imaging modality; imaging system; improved; molecular phenotype; novel; optical imaging; perfusion imaging; phase III trial; prevent; quality assurance; success; targeted imaging; tissue phantom; tool; web portal

Abstract Fluorescence-guided surgery is increasingly being adopted by surgeons for the potential to obtain real-time feedback, improving their ability to identify normal and diseased tissues through enhanced contrast. Yet, even with this growing adoption, there is a stark lack of standardized system characterization or routine performance monitoring, largely because the optical technologies vary considerably in their geometry, configuration, components and ultimately their uses. The lack of performance targets across vendors leads to a high inefficiency and irreproducibility between systems, and prevents the ability to exchange systems for the same use. One of the more complicated but critical factors with optical imaging in tissue is accounting for how tissue optical properties, spectral range and tissue layers/depths affect the image quality in non-linear and non- intuitive ways. QUEL Imaging has developed methods for printing optical reference targets with controlled optical properties and fluorescence inclusions of varying concentrations. In this application, we plan to expand these product offerings by incorporating new fluorophores and target designs. Our centralized web-portal will provide image analysis services to report metrics used for system characterization. Performance monitoring targets will be developed for the purpose of implementing QA protocols specific to imaging form-factors: endoscopic, close-box and open widefield systems. Our quality management system will be enhanced to align with ISO13485 and ensure NIST traceability of our products. New printing techniques will be explored to determine methods for further reducing production costs and improving scalability. This work will be supported and guided by a panel of industry, academic and medical experts who will meet bi-annually to discuss current and future needs to help better standardize this field.

抽象的 外科医生越来越多地采用荧光引导的手术，以获得实时的潜力 反馈，通过增强对比度提高其识别正常组织和患病组织的能力。但是，甚至 随着这种采用的日益增长，缺乏标准化的系统表征或常规性能 监视，主要是因为光学技术的几何形状，配置， 组件及其最终用途。供应商之间缺乏绩效目标导致很高 系统之间的效率低下和不可重复的性能，并防止交换系统的能力 使用。在组织中使用光学成像的最复杂但关键因素之一是考虑组织的方式 光学特性，光谱范围和组织层/深度影响非线性和非线性的图像质量 直观的方式。 Quel Imaging已开发了用受控打印光学参考目标的方法 浓度不同的光学特性和荧光包含。在此应用程序中，我们计划扩展 这些产品通过结合新的荧光团和目标设计。我们的集中式网络门户将 提供图像分析服务以报告用于系统表征的指标。性能监控 将开发目标，目的是实施特定于成像形式因子的质量检查协议： 内窥镜，关闭箱和开放广告系统。我们的质量管理系统将得到增强以保持一致 使用ISO13485，并确保我们的产品的可追溯性。将探索新的打印技术 确定进一步降低生产成本并提高可扩展性的方法。这项工作将得到支持 并在一组行业，学术和医学专家的指导下，他们将一生见面以讨论当前 未来需要帮助更好地标准化这一领域。