Clinical trial · Interventional
Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer
NCT07285564CI-TRIAL-00099022TEP MarginsrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head & Neck Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| micro PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- PET/CT of the specimen after surgery
- interventionNames
- Device: micro PET/CT
Primary outcomes (1)
- measure
- Evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant ENT tumors compared to definitive histological analysis (gold standard).
- timeFrame
- Surgery
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.