title: Characterizing the Utility and Limitations of Repurposing an Open-Field Optical Imaging Device for Fluorescence-Guided Surgery in Head and Neck Cancer Patients.
abstract: The purpose of this study was to assess the potential of U.S. Food and Drug Administration-cleared devices designed for indocyanine green-based perfusion imaging to identify cancer-specific bioconjugates with overlapping excitation and emission wavelengths. Recent clinical trials have demonstrated potential for fluorescence-guided surgery, but the time and cost of the approval process may impede clinical translation. To expedite this translation, we explored the feasibility of repurposing existing optical imaging devices for fluorescence-guided surgery.
  
  
  METHODS
  Consenting patients (n = 15) scheduled for curative resection were enrolled in a clinical trial evaluating the safety and specificity of cetuximab-IRDye800 (NCT01987375). Open-field fluorescence imaging was performed preoperatively and during the surgical resection. Fluorescence intensity was quantified using integrated instrument software, and the tumor-to-background ratio characterized fluorescence contrast.
  
  
  RESULTS
  In the preoperative clinic, the open-field device demonstrated potential to guide preoperative mapping of tumor borders, optimize the day of surgery, and identify occult lesions. Intraoperatively, the device demonstrated robust potential to guide surgical resections, as all peak tumor-to-background ratios were greater than 2 (range, 2.2-14.1). Postresection wound bed fluorescence was significantly less than preresection tumor fluorescence (P < 0.001). The repurposed device also successfully identified positive margins.
  
  
  CONCLUSIONS
  The open-field imaging device was successfully repurposed to distinguish cancer from normal tissue in the preoperative clinic and throughout surgical resection. This study illuminated the potential for existing open-field optical imaging devices with overlapping excitation and emission spectra to be used for fluorescence-guided surgery.
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Lindsay S
authors: LS
authors: Moore
authors: Department of Otolaryngology, Stanford University, Stanford, California elr@stanford.edu.
authors: Eben L
authors: EL
authors: Rosenthal
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Thomas K
authors: TK
authors: Chung
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.|Department of Surgery, University of Groningen, Groningen, The Netherlands.
authors: Esther
authors: E
authors: de Boer
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Neel
authors: N
authors: Patel
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Andrew C
authors: AC
authors: Prince
authors: Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Melissa L
authors: ML
authors: Korb
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Erika M
authors: EM
authors: Walsh
authors: Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: E Scott
authors: ES
authors: Young
authors: Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Todd M
authors: TM
authors: Stevens
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Kirk P
authors: KP
authors: Withrow
authors: Department of Oral and Maxillofacial Surgery, University of Alabama at Birmingham, Birmingham, Alabama; and.
authors: Anthony B
authors: AB
authors: Morlandt
authors: Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Joshua S
authors: JS
authors: Richman
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: William R
authors: WR
authors: Carroll
authors: Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Kurt R
authors: KR
authors: Zinn
authors: Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Jason M
authors: JM
authors: Warram
mesh_terms: D000328:Adult; D000368:Aged; D004867:Equipment Design; D019544:Equipment Failure Analysis; D017743:Equipment Reuse; D005260:Female; D006258:Head and Neck Neoplasms / Q000000981:diagnostic imaging* / Q000601:surgery*; D006801:Humans; D008297:Male; D000072662:Margins of Excision; D008856:Microscopy, Fluorescence / Q000295:instrumentation*; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D025321:Surgery, Computer-Assisted / Q000295:instrumentation* / Q000379:methods; D041622:Tomography, Optical / Q000295:instrumentation*; D016896:Treatment Outcome
keywords: fluorescence-guided surgery; head and neck cancer; optical imaging