EGFR-targeted fluorescence molecular imaging for intraoperative margin assessment in oral cancer patients: a phase II trial
de Wit, Jaron G; Vonk, Jasper; Voskuil, Floris J; de Visscher, Sebastiaan A H J; Schepman, Kees-Pieter; Hooghiemstra, Wouter T R; Linssen, Matthijs D; Elias, Sjoerd G; Halmos, Gyorgy B; Plaat, Boudewijn E C; Doff, Jan J; Rosenthal, Eben L; Robinson, Dominic; van der Vegt, Bert; Nagengast, Wouter B; van Dam, Gooitzen M; Witjes, Max J H
(2023) Nature Communications, volume 14, issue 1
(Article)
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
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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.
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Keywords: Carcinoma, Squamous Cell/diagnostic imaging, Cetuximab, Coloring Agents, ErbB Receptors, Humans, Margins of Excision, Molecular Imaging, Mouth Neoplasms/diagnostic imaging, Radiopharmaceuticals, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't
ISSN: 2041-1723
Publisher: Nature Publishing Group
Note: Publisher Copyright: © 2023, Springer Nature Limited.
(Peer reviewed)