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

Autor: de Wit JG; Department of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Vonk J; Department of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Voskuil FJ; Department of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.; Department of Pathology & Medical Biology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., de Visscher SAHJ; Department of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Schepman KP; Department of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Hooghiemstra WTR; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.; Department of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Linssen MD; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.; Department of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Elias SG; Department of Epidemiology, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands., Halmos GB; Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Plaat BEC; Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Doff JJ; Department of Pathology & Medical Biology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Rosenthal EL; Department of Otolaryngology, Vanderbilt University Medical Centre, Nashville, Tennessee, United States of America., Robinson D; Center for Optical Diagnostics and Therapy, Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands., van der Vegt B; Department of Pathology & Medical Biology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Nagengast WB; Department of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., van Dam GM; Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.; TRACER Europe B.V. / AxelaRx, Groningen, the Netherlands., Witjes MJH; Department of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands. m.j.h.witjes@umcg.nl.
Jazyk: angličtina
Zdroj: Nature communications [Nat Commun] 2023 Aug 16; Vol. 14 (1), pp. 4952. Date of Electronic Publication: 2023 Aug 16.
DOI: 10.1038/s41467-023-40324-8
Abstrakt: 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.
(© 2023. Springer Nature Limited.)
Databáze: MEDLINE
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