Literature DB >> 26449839

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.   

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.
© 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Entities:  

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

Mesh:

Year:  2015        PMID: 26449839      PMCID: PMC4772735          DOI: 10.2967/jnumed.115.158915

Source DB:  PubMed          Journal:  J Nucl Med        ISSN: 0161-5505            Impact factor:   10.057


  9 in total

Review 1.  Exploratory IND: a new regulatory strategy for early clinical drug development in the United States.

Authors:  N Sarapa
Journal:  Ernst Schering Res Found Workshop       Date:  2007

2.  American College of Clinical Pharmacology position statement on the use of microdosing in the drug development process.

Authors:  Joseph S Bertino; Howard E Greenberg; Michael D Reed
Journal:  J Clin Pharmacol       Date:  2007-04       Impact factor: 3.126

3.  Evaluation of frozen-section analysis of surgical margins in the treatment of breast cancer.

Authors:  G Novita; J R Filassi; C A Ruiz; M D Ricci; K M Pincerato; H R de Oliveira Filho; J M Soares; E C Baracat
Journal:  Eur J Gynaecol Oncol       Date:  2012       Impact factor: 0.196

4.  Accuracy of intraoperative frozen section in the evaluation of patients with adnexal mass: retrospective analysis of 748 cases with multivariate regression analysis.

Authors:  Derman Basaran; M Coskun Salman; Gokhan Boyraz; Ilker Selcuk; Alp Usubutun; Nejat Ozgul; Kunter Yuce
Journal:  Pathol Oncol Res       Date:  2014-05-22       Impact factor: 3.201

5.  Evaluation of frozen section margins in high-risk cutaneous squamous cell carcinomas of the head and neck.

Authors:  Kyle J Chambers; Stefan Kraft; Kevin Emerick
Journal:  Laryngoscope       Date:  2014-09-17       Impact factor: 3.325

6.  Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial.

Authors:  Walter Stummer; Uwe Pichlmeier; Thomas Meinel; Otmar Dieter Wiestler; Friedhelm Zanella; Hans-Jürgen Reulen
Journal:  Lancet Oncol       Date:  2006-05       Impact factor: 41.316

7.  Fluorescence-guided resection of glioblastoma multiforme by using 5-aminolevulinic acid-induced porphyrins: a prospective study in 52 consecutive patients.

Authors:  W Stummer; A Novotny; H Stepp; C Goetz; K Bise; H J Reulen
Journal:  J Neurosurg       Date:  2000-12       Impact factor: 5.115

8.  IND-directed safety and biodistribution study of intravenously injected cetuximab-IRDye800 in cynomolgus macaques.

Authors:  Kurt R Zinn; Melissa Korb; Sharon Samuel; Jason M Warram; David Dion; Cheryl Killingsworth; Jinda Fan; Trenton Schoeb; Theresa V Strong; Eben L Rosenthal
Journal:  Mol Imaging Biol       Date:  2015-02       Impact factor: 3.488

9.  Inert coupling of IRDye800CW to monoclonal antibodies for clinical optical imaging of tumor targets.

Authors:  Ruth Cohen; Marieke A Stammes; Inge Hc de Roos; Marijke Stigter-van Walsum; Gerard Wm Visser; Guus Ams van Dongen
Journal:  EJNMMI Res       Date:  2011-12-01       Impact factor: 3.138

  9 in total
  62 in total

1.  Shortwave infrared fluorescence imaging with the clinically approved near-infrared dye indocyanine green.

Authors:  Jessica A Carr; Daniel Franke; Justin R Caram; Collin F Perkinson; Mari Saif; Vasileios Askoxylakis; Meenal Datta; Dai Fukumura; Rakesh K Jain; Moungi G Bawendi; Oliver T Bruns
Journal:  Proc Natl Acad Sci U S A       Date:  2018-04-06       Impact factor: 11.205

Review 2.  Oncologic Procedures Amenable to Fluorescence-guided Surgery.

Authors:  Kiranya E Tipirneni; Jason M Warram; Lindsay S Moore; Andrew C Prince; Esther de Boer; Aditi H Jani; Irene L Wapnir; Joseph C Liao; Michael Bouvet; Nicole K Behnke; Mary T Hawn; George A Poultsides; Alexander L Vahrmeijer; William R Carroll; Kurt R Zinn; Eben Rosenthal
Journal:  Ann Surg       Date:  2017-07       Impact factor: 12.969

3.  Proceedings: Pathways for Successful Translation of New Imaging Agents and Modalities-Phase III Studies.

Authors:  Sanjiv S Gambhir; Lalitha K Shankar; Eben Rosenthal; Jason M Warram; Munir Ghesani; Thomas A Hope; Paula M Jacobs; Gunilla B Jacobson; Terri Wilson; Barry A Siegel
Journal:  J Nucl Med       Date:  2019-03-08       Impact factor: 10.057

4.  Setting Standards for Reporting and Quantification in Fluorescence-Guided Surgery.

Authors:  Charlotte Hoogstins; Jan Jaap Burggraaf; Marjory Koller; Henricus Handgraaf; Leonora Boogerd; Gooitzen van Dam; Alexander Vahrmeijer; Jacobus Burggraaf
Journal:  Mol Imaging Biol       Date:  2019-02       Impact factor: 3.488

5.  Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection.

Authors:  Willemieke S Tummers; Jason M Warram; Kiranya E Tipirneni; John Fengler; Paula Jacobs; Lalitha Shankar; Lori Henderson; Betsy Ballard; T Joshua Pfefer; Brian W Pogue; Jamey P Weichert; Michael Bouvet; Jonathan Sorger; Christopher H Contag; John V Frangioni; Michael F Tweedle; James P Basilion; Sanjiv S Gambhir; Eben L Rosenthal
Journal:  Cancer Res       Date:  2017-04-20       Impact factor: 12.701

Review 6.  Optical Surgical Navigation for Precision in Tumor Resections.

Authors:  Stefan Harmsen; Nutte Teraphongphom; Michael F Tweedle; James P Basilion; Eben L Rosenthal
Journal:  Mol Imaging Biol       Date:  2017-06       Impact factor: 3.488

7.  Characterizing the detection threshold for optical imaging in surgical oncology.

Authors:  Andrew C Prince; Aditi Jani; Melissa Korb; Kiranya E Tipirneni; Benjamin B Kasten; Eben L Rosenthal; Jason M Warram
Journal:  J Surg Oncol       Date:  2017-06-19       Impact factor: 3.454

Review 8.  Beyond the margins: real-time detection of cancer using targeted fluorophores.

Authors:  Ray R Zhang; Alexandra B Schroeder; Joseph J Grudzinski; Eben L Rosenthal; Jason M Warram; Anatoly N Pinchuk; Kevin W Eliceiri; John S Kuo; Jamey P Weichert
Journal:  Nat Rev Clin Oncol       Date:  2017-01-17       Impact factor: 66.675

9.  Activatable clinical fluorophore-quencher antibody pairs as dual molecular probes for the enhanced specificity of image-guided surgery.

Authors:  Girgis Obaid; Bryan Q Spring; Shazia Bano; Tayyaba Hasan
Journal:  J Biomed Opt       Date:  2017-08       Impact factor: 3.170

10.  Effect of charge localization on the in vivo optical imaging properties of near-infrared cyanine dye/monoclonal antibody conjugates.

Authors:  Kazuhide Sato; Alexander P Gorka; Tadanobu Nagaya; Megan S Michie; Yuko Nakamura; Roger R Nani; Vince L Coble; Olga V Vasalatiy; Rolf E Swenson; Peter L Choyke; Martin J Schnermann; Hisataka Kobayashi
Journal:  Mol Biosyst       Date:  2016-07-25
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