EGFR-targeted fluorescence molecular imaging for intraoperative margin assessment in oral cancer patients: a phase II trial

Jaron G. Wit, Jasper Vonk, Floris J. Voskuil, Sebastiaan A. H. J. Visscher, Kees-Pieter Schepman, Wouter T. R. Hooghiemstra, Matthijs D. Linssen, Sjoerd G. Elias, Gyorgy B. Halmos, Boudewijn E. C. Plaat, Jan J. Doff, Eben L. Rosenthal, Dominic Robinson, Bert Vegt, Wouter B. Nagengast, Gooitzen M. Dam and Max J. H. Witjes ()
Additional contact information
Jaron G. Wit: University of Groningen, University Medical Centre Groningen
Jasper Vonk: University of Groningen, University Medical Centre Groningen
Floris J. Voskuil: University of Groningen, University Medical Centre Groningen
Sebastiaan A. H. J. Visscher: University of Groningen, University Medical Centre Groningen
Kees-Pieter Schepman: University of Groningen, University Medical Centre Groningen
Wouter T. R. Hooghiemstra: University of Groningen, University Medical Centre Groningen
Matthijs D. Linssen: University of Groningen, University Medical Centre Groningen
Sjoerd G. Elias: University Medical Centre Utrecht, Utrecht University
Gyorgy B. Halmos: University of Groningen, University Medical Centre Groningen
Boudewijn E. C. Plaat: University of Groningen, University Medical Centre Groningen
Jan J. Doff: University of Groningen, University Medical Centre Groningen
Eben L. Rosenthal: Vanderbilt University Medical Centre
Dominic Robinson: Erasmus MC Cancer Institute
Bert Vegt: University of Groningen, University Medical Centre Groningen
Wouter B. Nagengast: University of Groningen, University Medical Centre Groningen
Gooitzen M. Dam: University of Groningen, University Medical Centre Groningen
Max J. H. Witjes: University of Groningen, University Medical Centre Groningen

Nature Communications, 2023, vol. 14, issue 1, 1-10

Abstract: Abstract Inadequate surgical margins occur frequently in oral squamous cell carcinoma surgery. Fluorescence molecular imaging (FMI) has been explored for intraoperative margin assessment, but data are limited to phase-I studies. In this single-arm phase-II study (NCT03134846), our primary endpoints were to determine the sensitivity, specificity and positive predictive value of cetuximab-800CW for tumor-positive margins detection. Secondary endpoints were safety, close margin detection rate and intrinsic cetuximab-800CW fluorescence. In 65 patients with 66 tumors, cetuximab-800CW was well-tolerated. Fluorescent spots identified in the surgical margin with signal-to-background ratios (SBR) of ≥2 identify tumor-positive margins with 100% sensitivity, 85.9% specificity, 58.3% positive predictive value, and 100% negative predictive value. An SBR of ≥1.5 identifies close margins with 70.3% sensitivity, 76.1% specificity, 60.5% positive predictive value, and 83.1% negative predictive value. Performing frozen section analysis aimed at the fluorescent spots with an SBR of ≥1.5 enables safe, intraoperative adjustment of surgical margins.

Date: 2023
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DOI: 10.1038/s41467-023-40324-8

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