About this trial
This multicenter prospective observational study will evaluate the value of dynamic FDG-PET LAFOV imaging during the initial therapeutic assessment of a head and neck cancer 3 months after completion of curative radiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient ≥ 18 years of age
Presenting with head and neck squamous cell carcinoma
Completed curative treatment with external radiation therapy
Eligible for dynamic LAFOV FDG-PET scan for therapeutic evaluation at 3 months
Disqualifiers
Hypersensitivity to 18F-FDG or other excipients contained in the contrast agent
Pregnancy or breastfeeding
History of treated upper gastrointestinal tract cancer
Other histology
Trial population
Patients treated with radiotherapy for curative purposes for squamous cell carcinoma of the upper aerodigestive tract.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Parameters obtained using the Patlak Direct IDIF reconstruction method, Ki mean, Ki max, DV mean and DV max (standards) in FDG-PET LAFOV in the residual disease and post-treatment inflammation groups
The reference test for the diagnosis of " residual diseases " and " post-radiation inflammation" will be based on the conclusion of the multidisciplinary team meeting ruling on the results of composite data, including clinical examination, pathological examination, morphological imaging (CT or MRI) and/or functional imaging (early evaluation PET). The index test will be based on FDG-PET LAFOV whose parameters obtained using the Patlak Direct IDIF, Ki mean, Ki max, DV mean and DV max (standards) in the residual disease and post-therapy inflammation groups.
Secondary outcomes
Standard Ki and DV parameters in LAFOV FDG-PET and anatomical pathology characteristics of tumours (p16 status, CPS, degree of tumour differentiation).
Dynamic (standard Ki and DV) and static (SUVmax, SUVmean, SUVpeak, MTV, TLG, textural features) parameters in LAFOV FDG-PET.
Ki and DV parameters in LAFOV FDG-PET and the occurrence of post-radiation toxicity
DV and Ki parameters derived from direct and indirect Patlak reconstructions with IDIF and/or PBIF.
Sponsors and contacts
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