Phase II: Fluorescence guided surgery standardization tools

摘要 手术引导手术越来越多地被外科医生采用，以获得实时的 反馈，提高他们的能力，以确定正常和病变组织通过增强对比度。但即使 随着这一应用的不断增加，标准化的系统特性或常规性能的缺乏是显而易见的 监测，主要是因为光学技术在它们的几何形状，配置， 组件及其最终用途。供应商之间缺乏性能目标， 系统之间的低效率和不可再现性，并且阻止了将系统交换为相同系统的能力 使用.组织中光学成像的更复杂但关键的因素之一是考虑组织如何 光学特性、光谱范围和组织层/深度以非线性和非线性方式影响图像质量。 直觉的方式。QUEL Imaging开发了用于打印光学参考目标的方法， 光学性质和不同浓度的荧光内含物。在这个应用程序中，我们计划扩展 这些产品通过结合新的荧光团和目标设计。我们的中央门户网站将 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，用于实施特定于成像形状因子的QA协议： 内窥镜、闭箱和开放式宽视野系统。我们的质量管理体系将得到加强， 符合ISO 13485标准，并确保我们产品的NIST可追溯性。将探索新的印刷技术， 确定进一步降低生产成本和提高可扩展性的方法。这项工作将得到支持 并由一个由工业界、学术界和医学专家组成的小组指导，他们将每两年举行一次会议，讨论当前的 和未来的需要，以帮助更好地标准化这一领域。

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.