Head & Neck Cancer
Conditions
Keywords
Margins, microPET/CT, specimen
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).
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
DEVICEmicro PET/CT
PET/T of the speciment after surgery
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactLise-Marie Roussel, MD
Backup ContactDoriane Richard, PhD
Outcome results
None listed