Multiple FGS devices have been FDA cleared for use in open and laparoscopic surgery. Despite the rapid growth of the field, there has been a lack of standardization methods. We propose a system evaluation pipeline through the use of photo-stable ICG fluorescence phantoms. The approach is validated across five different FDA-approved open-FGS systems which are characterized for: spatial resolution, sensitivity and linearity, imaging depth, depth of field, uniformity, spatial distortion, signal-background ratio, excitation wavelength bands and power. The results highlight how such a standardization approach can be successfully implemented for inter-system comparisons and to better understand features within each device.
SignificanceFluorescence 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.AimThis 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.ApproachThe 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.ResultsThe 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.ConclusionsDespite 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.
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