Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report

Abstract

Navigation with fluorescence guidance is emerging as a promising strategy to improve the efficacy of oncologic surgery in the last decade. The onus is on the surgical community to objectively assess the added value of this technique for routine use daily clinical practice, which will directly impact both the Food and Drug Administration (FDA) approval process and insurance reimbursement. In addition, it is critical to characterize the potential benefits over existing practices and to elucidate both the costs and safety risks. This report is the result a consensus meeting of the American Society of Image Guided Surgery (ASIGS) on February 6th, 2015 at Miami, Florida and reflects a consensus of the participant’s opinions. Our objective is to critically evaluate the platform technology and its optical imaging agents and make recommendations for successful clinical trial development for clinical implementation of this highly promising approach in oncologic surgery.

Characterizing the Utility and Limitations of Repurposing an Open-Field Optical Imaging Device for Fluorescence-Guided Surgery in Head and Neck Cancer Patients

“…Clinical translation of these components has been limited because the development and approval of standardized imaging devices and agents is expensive, of unknown toxicity, and time-intensive, with limited expected return compared with traditional therapeutic agents (7). There is a critical need for industry to develop this technology in order to create a clinical infrastructure for routine use.…”

“…Thus, one device could be used for several fluorescent agents and one agent could be used with multiple devices. This strategy is not without its own unique set of challenges, including the use of a fluorophore that is not optimal for the spectrum of the device and, in the case of repurposed devices, limited intraoperative applications due to size, ergonomics, or integrated software constraints (7). However, repurposing a preapproved device ensures patient safety (as the device's safety profile is already known) and is substantially more time-, cost-, and resourceeffective (7).…”

“…This strategy is not without its own unique set of challenges, including the use of a fluorophore that is not optimal for the spectrum of the device and, in the case of repurposed devices, limited intraoperative applications due to size, ergonomics, or integrated software constraints (7). However, repurposing a preapproved device ensures patient safety (as the device's safety profile is already known) and is substantially more time-, cost-, and resourceeffective (7). Repurposing existing optical imaging devices for use in fluorescence-guided surgery may therefore provide the most straightforward and efficient path to the clinic.…”

“…The intraoperative identification of tumor margins is inexact, as surgeons must rely on visual and manual identification of subtle tissue irregularities to discern tumor borders. Nonspecific anatomic imaging modalities can identify tumor boundaries with millimeter resolution and are being increasingly incorporated into the operating room; however, these modalities cannot provide real-time information and cannot easily be applied to the surgical field of view (7). Frozensection analysis provides guidance for intraoperative margin assessment but is time-intensive and can sample only a fraction of the wound bed (8).…”

“…One option is to pair the fluorescent agent and the device so that they are required to be used together, as is currently done for optical agents (7,21,22). An alternative approach to streamline the clinical implementation of fluorescence surgical navigation is to allow new or repurposed devices to be used with several fluorescent agents that have excitation and emission spectra falling within the range of the device parameters.…”