Assessment of open-field fluorescence guided surgery systems: implementing a standardized method for characterization and comparison.

Abstract

Fluorescence guided surgery (FGS) has demonstrated improvements in decision making and patient outcomes for a wide range of surgical procedures. Not only can FGS systems provide a higher level of structural perfusion accuracy in tissue reconstruction cases but they can also serve for real-time functional characterization. Multiple FGS devices have been Food and Drug administration (FDA) cleared for use in open and laparoscopic surgery. Despite the rapid growth of the field, there has been a lack standardization methods. This work overviews commonalities inherent to optical imaging methods that can be exploited to produce such a standardization procedure. Furthermore, a system evaluation pipeline is proposed and executed through the use of photo-stable indocyanine green fluorescence phantoms. Five different FDA-approved open-field FGS systems are used and evaluated with the proposed method. The proposed pipeline encompasses the following characterization: (1)imaging spatial resolution and sharpness, (2)sensitivity and linearity, (3)imaging depth into tissue, (4)imaging system DOF, (5)uniformity of illumination, (6)spatial distortion, (7)signal to background ratio, (8)excitation bands, and (9)illumination wavelength and power. The results highlight how such a standardization approach can be successfully implemented for inter-system comparisons as well as how to better understand essential features within each FGS setup. Despite clinical use being the end goal, a robust yet simple standardization pipeline before clinical trials, such as the one presented herein, should benefit regulatory agencies, manufacturers, and end-users to better assess basic performance and improvements to be made in next generation FGS systems.