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Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07285564•Centre Henri Becquerel

View on ClinicalTrials.gov

Summary

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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

Centre Henri Becquerel

Rouen, France

Key Dates

Start Date

November 7, 2025

Primary Completion Date

March 15, 2026

Completion Date

June 15, 2026

Last Updated

December 16, 2025

Enrollment

ESTIMATED participants

Conditions

Head & Neck Cancer

Interventions

micro PET/CT

DEVICE

Contacts

Lise-Marie Roussel, MD

CONTACT

+33232082222 lise-marie.roussel@chb.unicancer.fr

Doriane Richard, PhD

CONTACT

+33232082985 doriane.richard@chb.unicancer.fr

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Head & Neck Squamous Cell CarcinomaHead & Neck Cancer+1 more

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SUSPENDEDPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

SL-28 for Advanced Solid Tumours

Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma

PCA062 in pCAD-positive Tumors.

Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)