Review of fluorescence guided surgery systems: identification of key performance capabilities beyond indocyanine green imaging.

Alisha V Dsouza,Eric R Henderson,Huiyun Lin,Kimberley S Samkoe,Brian W Pogue

doi:10.1117/1.jbo.21.8.080901

Abstract

There is growing interest in using fluorescence imaging instruments to guide surgery, and the leading options for open-field imaging are reviewed here. While the clinical fluorescence-guided surgery (FGS) field has been focused predominantly on indocyanine green (ICG) imaging, there is accelerated development of more specific molecular tracers. These agents should help advance new indications for which FGS presents a paradigm shift in how molecular information is provided for resection decisions. There has been a steady growth in commercially marketed FGS systems, each with their own differentiated performance characteristics and specifications. A set of desirable criteria is presented to guide the evaluation of instruments, including: (i) real-time overlay of white-light and fluorescence images, (ii) operation within ambient room lighting, (iii) nanomolar-level sensitivity, (iv) quantitative capabilities, (v) simultaneous multiple fluorophore imaging, and (vi) ergonomic utility for open surgery. In this review, United States Food and Drug Administration 510(k) cleared commercial systems and some leading premarket FGS research systems were evaluated to illustrate the continual increase in this performance feature base. Generally, the systems designed for ICG-only imaging have sufficient sensitivity to ICG, but a fraction of the other desired features listed above, with both lower sensitivity and dynamic range. In comparison, the emerging research systems targeted for use with molecular agents have unique capabilities that will be essential for successful clinical imaging studies with low-concentration agents or where superior rejection of ambient light is needed. There is no perfect imaging system, but the feature differences among them are important differentiators in their utility, as outlined in the data and tables here.

Highlights

There has been an explosion of interest in fluorescence-guided surgery, which has led to a steady demand for new commercially developed and approved fluorescence imaging devices
There are several new fluorescence imagers that have been cleared for the market by the 510(k) process at the United States Food and Drug Administration (FDA) for open-surgical use with indocyanine green (ICG)
We describe the key engineering design criteria and the desirable features of a fluorescence guidance system for open-surgical use; this discussion of desirable features is supplemented with a description of system instrumentation in the sections that will follow

Summary

Introduction

There has been an explosion of interest in fluorescence-guided surgery, which has led to a steady demand for new commercially developed and approved fluorescence imaging devices. For the greatest clinical impact, an imaging system needs to provide a solution to the immediate clinical goal with important new information that affects the patient outcome in a way that seamlessly blends into current clinical workflow. New commercial research systems with important features are regularly emerging. There is often a disconnect between this emergent technology and the surgeons’ needs and flexibility.[1] Several reviews discuss the design, applications, and need for such imagers and tabulate the specifications of available imagers in the market.[2,3,4,5,6,7] none of them provides direct guidance on how to choose the right imager based on objective criteria. IRDye 800CW IRDye 680RD ∼1nM ∼5nM NA ∼75pM On Yes ∼10nM ∼5nM Low No ∼5nM —. ∼15nM — Low No ∼50pMa — On Yes ∼60pMd — Quantification—Linearity

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Discussion

Conclusion