Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report
Eben L Rosenthal, Jason M Warram, Esther de Boer, James P Basilion, Merrill A Biel, Matthew Bogyo, Michael Bouvet, Brian E Brigman, Yolonda L Colson, Steven R DeMeester, Geoffrey C Gurtner, Takeaki Ishizawa, Paula M Jacobs, Stijn Keereweer, Joseph C Liao, Quyen T Nguyen, James M Olson, Keith D Paulsen, Dwaine Rieves, Baran D Sumer, Michael F Tweedle, Alexander L Vahrmeijer, Jamey P Weichert, Brian C Wilson, Michael R Zenn, Kurt R Zinn, Gooitzen M van Dam, Eben L Rosenthal, Jason M Warram, Esther de Boer, James P Basilion, Merrill A Biel, Matthew Bogyo, Michael Bouvet, Brian E Brigman, Yolonda L Colson, Steven R DeMeester, Geoffrey C Gurtner, Takeaki Ishizawa, Paula M Jacobs, Stijn Keereweer, Joseph C Liao, Quyen T Nguyen, James M Olson, Keith D Paulsen, Dwaine Rieves, Baran D Sumer, Michael F Tweedle, Alexander L Vahrmeijer, Jamey P Weichert, Brian C Wilson, Michael R Zenn, Kurt R Zinn, Gooitzen M van Dam
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.
© 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
Source: PubMed