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

Eben L Rosenthal¹, Jason M Warram², Esther de Boer³, James P Basilion⁴, Merrill A Biel⁵, Matthew Bogyo⁶, Michael Bouvet⁷, Brian E Brigman⁸, Yolonda L Colson⁹, Steven R DeMeester¹⁰, Geoffrey C Gurtner¹¹, Takeaki Ishizawa¹², Paula M Jacobs¹³, Stijn Keereweer¹⁴, Joseph C Liao¹⁵, Quyen T Nguyen¹⁶, James M Olson¹⁷, Keith D Paulsen¹⁸, Dwaine Rieves¹⁹, Baran D Sumer²⁰, Michael F Tweedle²¹, Alexander L Vahrmeijer²², Jamey P Weichert²³, Brian C Wilson²⁴, Michael R Zenn²⁵, Kurt R Zinn²⁶, Gooitzen M van Dam²⁷

Affiliations

¹ Department of Otolaryngology, Stanford University, Stanford, California elr@stanford.edu.
² Division of Otolaryngology, Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama.
³ 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.
⁴ Case Center for Imaging Research, NFCR Center for Molecular Imaging, Department of Radiology Case Western Reserve University, Cleveland, Ohio.
⁵ Department of Otolaryngology-Head and Neck Surgery, University of Minnesota, Minneapolis, Minnesota.
⁶ Department of Pathology, Stanford School of Medicine, Stanford, California Department of Cancer Biology Program, Stanford School of Medicine, Stanford, California.
⁷ Department of Surgery, University of California San Diego, La Jolla, California.
⁸ Division of Orthopaedic Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina.
⁹ Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
¹⁰ Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California.
¹¹ Hagey Laboratory for Pediatric Regenerative Medicine, Division of Plastic and Reconstructive Surgery, Department of Surgery, Stanford University School of Medicine, Stanford, California.
¹² Artificial Organ and Transplantation Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
¹³ Cancer Imaging Program, DCTD, NCI, Bethesda, Maryland.
¹⁴ Department of Otorhinolaryngology Head and Neck Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
¹⁵ Department of Urology and Bio-X Program, Stanford University School of Medicine, Stanford, California.
¹⁶ Division of Head and Neck Surgery, University of California San Diego, San Diego, California.
¹⁷ Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington Seattle Children's Hospital & Regional Medical Center, Seattle, Washington.
¹⁸ Department of Diagnostic Radiology, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire.
¹⁹ NDA Partners LLC, Washington, District of Columbia.
²⁰ Department of Otolaryngology, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.
²¹ Department of Radiology, The Wright Center for Innovation in Biomedical Imaging, The Ohio State University, Columbus, Ohio.
²² Department of Surgery, Leiden, University Medical Center, Leiden, The Netherlands.
²³ Department of Radiology, University of Wisconsin, Madison, Wisconsin.
²⁴ Princess Margaret Cancer Centre, UHN, Toronto, Ontario, Canada Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.
²⁵ Plastic and Reconstructive Surgery, Duke University Medical Center, Durham, North Carolina; and.
²⁶ Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama.
²⁷ 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).

PMID: 26449839
PMCID: PMC4772735
DOI: 10.2967/jnumed.115.158915

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

Eben L Rosenthal et al. J Nucl Med. 2016 Jan.

. 2016 Jan;57(1):144-50.

doi: 10.2967/jnumed.115.158915. Epub 2015 Oct 8.

Authors

Affiliations

¹ Department of Otolaryngology, Stanford University, Stanford, California elr@stanford.edu.
² Division of Otolaryngology, Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama.
³ 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.
⁴ Case Center for Imaging Research, NFCR Center for Molecular Imaging, Department of Radiology Case Western Reserve University, Cleveland, Ohio.
⁵ Department of Otolaryngology-Head and Neck Surgery, University of Minnesota, Minneapolis, Minnesota.
⁶ Department of Pathology, Stanford School of Medicine, Stanford, California Department of Cancer Biology Program, Stanford School of Medicine, Stanford, California.
⁷ Department of Surgery, University of California San Diego, La Jolla, California.
⁸ Division of Orthopaedic Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina.
⁹ Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
¹⁰ Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California.
¹¹ Hagey Laboratory for Pediatric Regenerative Medicine, Division of Plastic and Reconstructive Surgery, Department of Surgery, Stanford University School of Medicine, Stanford, California.
¹² Artificial Organ and Transplantation Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
¹³ Cancer Imaging Program, DCTD, NCI, Bethesda, Maryland.
¹⁴ Department of Otorhinolaryngology Head and Neck Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
¹⁵ Department of Urology and Bio-X Program, Stanford University School of Medicine, Stanford, California.
¹⁶ Division of Head and Neck Surgery, University of California San Diego, San Diego, California.
¹⁷ Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington Seattle Children's Hospital & Regional Medical Center, Seattle, Washington.
¹⁸ Department of Diagnostic Radiology, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire.
¹⁹ NDA Partners LLC, Washington, District of Columbia.
²⁰ Department of Otolaryngology, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.
²¹ Department of Radiology, The Wright Center for Innovation in Biomedical Imaging, The Ohio State University, Columbus, Ohio.
²² Department of Surgery, Leiden, University Medical Center, Leiden, The Netherlands.
²³ Department of Radiology, University of Wisconsin, Madison, Wisconsin.
²⁴ Princess Margaret Cancer Centre, UHN, Toronto, Ontario, Canada Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.
²⁵ Plastic and Reconstructive Surgery, Duke University Medical Center, Durham, North Carolina; and.
²⁶ Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama.
²⁷ 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).

PMID: 26449839
PMCID: PMC4772735
DOI: 10.2967/jnumed.115.158915

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.

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References

1. Stummer W, Novotny A, Stepp H, Goetz C, Bise K, Reulen HJ. Fluorescence-guided resection of glioblastoma multiforme by using 5-aminolevulinic acid-induced porphyrins: a prospective study in 52 consecutive patients. J Neurosurg. 2000;93:1003–1013. - PubMed
1. Stummer W, Pichlmeier U, Meinel T, et al. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006;7:392–401. - PubMed
1. Bertino JS, Jr, Greenberg HE, Reed MD American College of Clinical P. American College of Clinical Pharmacology position statement on the use of microdosing in the drug development process. J Clin Pharmacol. 2007;47:418–422. - PubMed
1. Sarapa N. Exploratory IND: a new regulatory strategy for early clinical drug development in the United States. Ernst Schering Res Found Workshop. 2007:151–163. - PubMed
1. Zinn KR, Korb M, Samuel S, et al. IND-Directed Safety and Biodistribution Study of Intravenously Injected Cetuximab-IRDye800 in Cynomolgus Macaques. Mol Imaging Biol 2014 - PMC - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

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Medical