Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer (TEP Margins)

December 2, 2025 updated by: Centre Henri Becquerel
The purpose of this study is to evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant Head and neck cancer compared to definitive histological analysis (gold standard).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In approximately 20% of cases, surgical margins are considered insufficient. The only tool currently available intraoperatively to assess the quality of surgical resection is the extemporaneous examination. This has a sensitivity of only 10%.

The objective is therefore to evaluate the performance of another tool, available intraoperatively, to help surgeons assess the quality of their resection. Currently, micro-PET-CT allows for the evaluation of surgical specimens (CE marking and FDA approval obtained). Its performance in the evaluation of surgical margins remains to be demonstrated. This is the subject of the present study.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent
  • Adult, male or female, aged 18 or over
  • Patient with a malignant tumor of the oral cavity, oropharynx, hypopharynx, larynx, sinuses, or salivary glands, regardless of lymph node status (any N) M0, operable
  • Member or beneficiary of a social security plan

Exclusion Criteria:

  • Child-Pugh C liver failure
  • Patients under guardianship, conservatorship, or legal protection
  • Patients deprived of their liberty
  • Pregnant or breastfeeding women
  • Hypersensitivity to 18F-FDG or any of its excipients (ethanol or water for injection)
  • Uncontrolled diabetes
  • Moderate to end-stage renal failure, stage IIIB to V (glomerular filtration rate less than 44 mL/min/1.73 m²)
  • Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, or geographical issues).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
PET/CT of the specimen after surgery
Device: micro PET/CT
PET/T of the speciment after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant ENT tumors compared to definitive histological analysis (gold standard).
Time Frame: Surgery
Estimate the performance of micro-FDG PET in defining surgical margins and compare with histology by measuring the number of quadrants affected by each technique on the surgical specimen
Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Lise-Marie Roussel, MD, Centre Henri Becquerel
  • Principal Investigator: Sebastien Hapdey, PhD, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB25.06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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