Phase II: Fluorescence guided surgery standardization tools

摘要 荧光引导手术正越来越多地被外科医生采用，因为它可能获得实时 通过增强对比度，提高他们识别正常和病变组织的能力。然而，即使是 随着这种日益增长的采用，明显缺乏标准化的系统特征或常规性能 监控，很大程度上是因为光学技术在其几何结构、配置、 组件以及它们的最终用途。所有供应商都缺乏业绩目标，导致了 系统之间的低效和不可再生性，并阻碍了以系统换取相同系统的能力 使用。在组织中进行光学成像的一个更复杂但也是关键的因素是如何解释组织 光学特性、光谱范围和组织层/深度影响图像质量的非线性和非线性 直观的方式。QUEL成像公司已经开发出打印光学参考目标的方法 不同浓度的光学性质和荧光包裹体。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靶标设计来提供。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 将为实施特定于成像外形规格的QA协议而开发目标： 内窥镜、封闭式和开放式宽视场系统。我们的质量管理体系将得到加强，以符合 符合ISO13485标准，并确保我们产品的NIST可追溯性。将探索新的印刷技术，以 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 并由一个由行业、学术和医疗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 未来需要帮助更好地规范这一领域。

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.