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

J Nucl Med. 2016 Jan;57(1):144-50. doi: 10.2967/jnumed.115.158915. Epub 2015 Oct 8.

Abstract

Navigation with fluorescence guidance has emerged in the last decade as a promising strategy to improve the efficacy of oncologic surgery. To achieve routine clinical use, the onus is on the surgical community to objectively assess the value of this technique. This assessment may facilitate both Food and Drug Administration approval of new optical imaging agents and reimbursement for the imaging procedures. It is critical to characterize fluorescence-guided procedural benefits over existing practices and to elucidate both the costs and the safety risks. This report is the result of a meeting of the International Society of Image Guided Surgery (www.isigs.org) on February 6, 2015, in Miami, Florida, and reflects a consensus of the participants' opinions. Our objective was to critically evaluate the imaging platform technology and optical imaging agents and to make recommendations for successful clinical trial development of this highly promising approach in oncologic surgery.

Keywords: ISIGS; consensus report; fluorescence-guided surgery; regulatory guidance.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials, Phase I as Topic
  • Consensus*
  • Endpoint Determination
  • Government Regulation
  • Humans
  • Neoplasms / diagnosis
  • Neoplasms / surgery*
  • Optical Imaging / adverse effects
  • Optical Imaging / instrumentation
  • Optical Imaging / methods*
  • Patient Safety
  • Research Report*
  • Surgery, Computer-Assisted*
  • Translational Medical Research*
  • United States
  • United States Food and Drug Administration