Phase II: Fluorescence guided surgery standardization tools

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.