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Clinical Trials in France / NCT07285564
Recruiting Not applicable

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

NCT07285564 · tracked via the Priya Life Science France tracker
Sponsor
Centre Henri Becquerel
Phase
Not applicable
Started
2025-11-07
Last updated
2025-12-16

Condition(s) studied

Head & Neck Cancer

Investigational drug(s) / intervention(s)

micro PET/CT

micro PET/CT: PET/T of the speciment after surgery

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Centre Henri Becquerel Rouen France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07285564 on ClinicalTrials.gov ↗ ← All trials in France