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

Author

Listed:
  • 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
    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
    University of Groningen, University Medical Centre Groningen)

  • Matthijs D. Linssen

    (University of Groningen, University Medical Centre Groningen
    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
    TRACER Europe B.V. / AxelaRx)

  • Max J. H. Witjes

    (University of Groningen, University Medical Centre Groningen)

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.

Suggested Citation

  • 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 , 2023. "EGFR-targeted fluorescence molecular imaging for intraoperative margin assessment in oral cancer patients: a phase II trial," Nature Communications, Nature, vol. 14(1), pages 1-10, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-40324-8
    DOI: 10.1038/s41467-023-40324-8
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    References listed on IDEAS

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    1. Guolan Lu & Naoki Nishio & Nynke S. Berg & Brock A. Martin & Shayan Fakurnejad & Stan Keulen & Alexander D. Colevas & Greg M. Thurber & Eben L. Rosenthal, 2020. "Co-administered antibody improves penetration of antibody–dye conjugate into human cancers with implications for antibody–drug conjugates," Nature Communications, Nature, vol. 11(1), pages 1-11, December.
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