Evidence map›Paper›PMID 37587149›Full record

Trial reportNature communications2023

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

Jaron G de Wit, Jasper Vonk, Floris J Voskuil, Sebastiaan A H J de Visscher, Kees-Pieter Schepman, Wouter T R Hooghiemstra, Matthijs D Linssen, Sjoerd G Elias, Gyorgy B Halmos, Boudewijn E C Plaat and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03134846 (Image Guided Surgery for Margin Assessment of Head and Neck Cancer Using Cetuximab-IRDye800CW cONjugate), which is not on this map. Cited by 57 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 1 pooled it
27.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03134846 phase1 / phase2unknown statusnot on this map

Image Guided Surgery for Margin Assessment of Head and Neck Cancer Using Cetuximab-IRDye800CW cONjugate

TypeinterventionalSponsorUniversity Medical Center GroningenRan2017 to 2022Enrolled79ConditionsHead and Neck Squamous Cell Carcinoma, Margin AssessmentArmsCetuximab-IRDye800CW
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Interim Phase II Results Using Panitumumab-IRDye800CW during Transoral Robotic Surgery in Patients with Oropharyngeal Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  7. Article
  8. Review
  9. Review
  10. Review
  11. Automated cGMP Radiosynthesis of [Molecular imaging and biology · 2026
    Article
  12. Review
  13. Article
  14. Article
  15. Translation of Intraoperative Molecular Imaging for Clinical Use.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 4 institutions in 2 countries.

Jaron G de Wit *Department of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Jasper Vonk *Department of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Floris J VoskuilDepartment of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.ORCID http://orcid.org/0000-0003-3740-4554
Sebastiaan A H J de VisscherDepartment of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.ORCID http://orcid.org/0000-0001-8964-5427
Kees-Pieter SchepmanDepartment of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Wouter T R HooghiemstraDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Matthijs D LinssenDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Sjoerd G EliasDepartment of Epidemiology, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.
Gyorgy B HalmosDepartment of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Boudewijn E C PlaatDepartment of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.ORCID http://orcid.org/0000-0001-8631-7727
Jan J DoffDepartment of Pathology & Medical Biology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.ORCID http://orcid.org/0000-0002-1618-2588
Eben L RosenthalDepartment of Otolaryngology, Vanderbilt University Medical Centre, Nashville, Tennessee, United States of America.
Dominic RobinsonCenter for Optical Diagnostics and Therapy, Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Bert van der VegtDepartment of Pathology & Medical Biology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.ORCID http://orcid.org/0000-0002-2613-1506
Wouter B NagengastDepartment of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Gooitzen M van DamDepartment of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Max J H WitjesDepartment of Oral & Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands. m.j.h.witjes@umcg.nl.ORCID http://orcid.org/0000-0002-4135-3246
University Medical Center Groningen · NLErasmus MC Cancer Institute · NLUtrecht University · NLVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Carcinoma, Squamous CellMouth NeoplasmsCetuximabColoring AgentsErbB ReceptorsHumansMargins of ExcisionMolecular ImagingRadiopharmaceuticalsCetuximabColoring AgentsEGFR protein, humanErbB ReceptorsRadiopharmaceuticals

Identifiers

PMID37587149
PMCPMC10432510
OpenAlexW4385874418

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.