Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months post-curative radiotherapy

Secondary outcomes

1

Standard Ki and DV parameters in LAFOV FDG-PET and anatomical pathology characteristics of tumours (p16 status, CPS, degree of tumour differentiation).

Time frame
3 months post-curative radiotherapy
2

Dynamic (standard Ki and DV) and static (SUVmax, SUVmean, SUVpeak, MTV, TLG, textural features) parameters in LAFOV FDG-PET.

Time frame
3 months post-curative radiotherapy
3

Ki and DV parameters in LAFOV FDG-PET and the occurrence of post-radiation toxicity

Time frame
3 months post-curative radiotherapy
4

DV and Ki parameters derived from direct and indirect Patlak reconstructions with IDIF and/or PBIF.

Time frame
3 months post-curative radiotherapy

Other outcomes

Sponsors and contacts

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