title: Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report.
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.
authors.affiliation: Department of Otolaryngology, Stanford University, Stanford, California elr@stanford.edu.
authors.forename: Eben L
authors.initials: EL
authors.lastname: Rosenthal
authors.affiliation: Division of Otolaryngology, Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Jason M
authors.initials: JM
authors.lastname: Warram
authors.affiliation: Division of Otolaryngology, Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: Esther
authors.initials: E
authors.lastname: de Boer
authors.affiliation: Case Center for Imaging Research, NFCR Center for Molecular Imaging, Department of Radiology Case Western Reserve University, Cleveland, Ohio.
authors.forename: James P
authors.initials: JP
authors.lastname: Basilion
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Merrill A
authors.initials: MA
authors.lastname: Biel
authors.affiliation: Department of Pathology, Stanford School of Medicine, Stanford, California Department of Cancer Biology Program, Stanford School of Medicine, Stanford, California.
authors.forename: Matthew
authors.initials: M
authors.lastname: Bogyo
authors.affiliation: Department of Surgery, University of California San Diego, La Jolla, California.
authors.forename: Michael
authors.initials: M
authors.lastname: Bouvet
authors.affiliation: Division of Orthopaedic Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina.
authors.forename: Brian E
authors.initials: BE
authors.lastname: Brigman
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Yolonda L
authors.initials: YL
authors.lastname: Colson
authors.affiliation: Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California.
authors.forename: Steven R
authors.initials: SR
authors.lastname: DeMeester
authors.affiliation: Hagey Laboratory for Pediatric Regenerative Medicine, Division of Plastic and Reconstructive Surgery, Department of Surgery, Stanford University School of Medicine, Stanford, California.
authors.forename: Geoffrey C
authors.initials: GC
authors.lastname: Gurtner
authors.affiliation: Artificial Organ and Transplantation Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Takeaki
authors.initials: T
authors.lastname: Ishizawa
authors.affiliation: Cancer Imaging Program, DCTD, NCI, Bethesda, Maryland.
authors.forename: Paula M
authors.initials: PM
authors.lastname: Jacobs
authors.affiliation: Department of Otorhinolaryngology Head and Neck Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Stijn
authors.initials: S
authors.lastname: Keereweer
authors.affiliation: Department of Urology and Bio-X Program, Stanford University School of Medicine, Stanford, California.
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Liao
authors.affiliation: Division of Head and Neck Surgery, University of California San Diego, San Diego, California.
authors.forename: Quyen T
authors.initials: QT
authors.lastname: Nguyen
authors.affiliation: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington Seattle Children's Hospital & Regional Medical Center, Seattle, Washington.
authors.forename: James M
authors.initials: JM
authors.lastname: Olson
authors.affiliation: Department of Diagnostic Radiology, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Paulsen
authors.affiliation: NDA Partners LLC, Washington, District of Columbia.
authors.forename: Dwaine
authors.initials: D
authors.lastname: Rieves
authors.affiliation: Department of Otolaryngology, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Baran D
authors.initials: BD
authors.lastname: Sumer
authors.affiliation: Department of Radiology, The Wright Center for Innovation in Biomedical Imaging, The Ohio State University, Columbus, Ohio.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Tweedle
authors.affiliation: Department of Surgery, Leiden, University Medical Center, Leiden, The Netherlands.
authors.forename: Alexander L
authors.initials: AL
authors.lastname: Vahrmeijer
authors.affiliation: Department of Radiology, University of Wisconsin, Madison, Wisconsin.
authors.forename: Jamey P
authors.initials: JP
authors.lastname: Weichert
authors.affiliation: Princess Margaret Cancer Centre, UHN, Toronto, Ontario, Canada Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Brian C
authors.initials: BC
authors.lastname: Wilson
authors.affiliation: Plastic and Reconstructive Surgery, Duke University Medical Center, Durham, North Carolina; and.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zenn
authors.affiliation: Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Kurt R
authors.initials: KR
authors.lastname: Zinn
authors.affiliation: Department of Surgery, Nuclear Medicine and Molecular Imaging and Intensive Care, University Medical Center Groningen, University of Groningen, The Netherlands, on behalf of the International Society of Image Guided Surgery (ISIGS).
authors.forename: Gooitzen M
authors.initials: GM
authors.lastname: van Dam
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D023381:Endpoint Determination; D033161:Government Regulation; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis / Q000601:surgery*; D061848:Optical Imaging / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D061214:Patient Safety; D058028:Research Report; D025321:Surgery, Computer-Assisted; D057170:Translational Research, Biomedical; D014481:United States; D014486:United States Food and Drug Administration
keywords: ISIGS; consensus report; fluorescence-guided surgery; regulatory guidance