Using 18F-FDG Micro-PET/CT to Check Surgical Margins after Head and Neck Cancer Surgery
Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer
This study will test whether a micro-PET/CT scan of the removed tumor can help surgeons tell if they got all the cancer in adults having operable head and neck cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Henri Becquerel Academic / other |
| Locations | 1 site (Rouen) |
| Trial ID | NCT07285564 on ClinicalTrials.gov |
What this trial studies
The study uses 18F-FDG micro-PET/CT imaging of surgically removed specimens performed intraoperatively and compares the imaging findings to the definitive histological analysis as the gold standard. Imaging will be done on specimens from patients undergoing surgery for malignant tumors of the oral cavity, oropharynx, hypopharynx, larynx, sinuses, or salivary glands. The aim is to measure diagnostic performance (sensitivity, specificity) for detecting involved margins and to compare this approach with current intraoperative tools. The micro-PET/CT device used is CE-marked and FDA-cleared for specimen imaging, but its margin-detection accuracy is being specifically tested here.
Who should consider this trial
Good fit: Adults (18+) with an operable malignant tumor of the oral cavity, oropharynx, hypopharynx, larynx, sinuses, or salivary glands (M0) who can give informed consent and are covered by a social security plan.
Not a fit: Patients who are pregnant or breastfeeding, have uncontrolled diabetes, severe renal or liver failure, are legally protected/incarcerated, or who cannot comply with procedures are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this technique could give surgeons faster, more accurate information about margin status during surgery and reduce the need for additional operations.
How similar studies have performed: Specimen micro-PET/CT has been used and is approved for imaging removed tissue, but its specific accuracy for detecting positive surgical margins has not yet been proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Rouen
- Centre Henri Becquerel — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Sebastien Hapdey, PhD — Centre Henri Becquerel
- Study coordinator: Lise-Marie Roussel, MD
- Email: lise-marie.roussel@chb.unicancer.fr
- Phone: +33232082222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.