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

NCT07285564 | Recruiting

• 1 other identifier: CHB25.06
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Head & Neck Cancer

Keywords

Margins; microPET/CT; specimen

Outcome Measures

Primary Outcomes (1)

• Evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant ENT tumors compared to definitive histological analysis (gold standard).

  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

Study Arms (1)

Experimental

EXPERIMENTAL

PET/CT of the specimen after surgery

Device: micro PET/CT

Interventions

micro PET/CT DEVICE

PET/T of the speciment after surgery

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastien Hapdey, PhD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

• Lise-Marie Roussel, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise-Marie Roussel, MD

CONTACT

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

Doriane Richard, PhD

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 16, 2025
• Study Start: November 7, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-11

Locations

FR (1)