Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: micro PET/CT.
- Who it may be relevant to
- Registry conditions: Head & Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device micro PET/CT
PET/T of the speciment after surgery
Primary outcome measures
- Evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant ENT tumors compared to definitive histological analysis (gold standard). [Time frame: Surgery]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Henri Becquerel — Rouen
Identifiers
NCT: NCT07285564 · CHB25.06