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Recruiting NCT07417605

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.

— Observational Head & Neck Squamous Cell Carcinoma

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Head & Neck Squamous Cell Carcinoma. 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 →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 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 [Time frame: 3 months post-curative radiotherapy]
Secondary outcome measures (5)
  • 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]
  • 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]
  • Ki and DV parameters in LAFOV FDG-PET and the occurrence of post-radiation toxicity [Time frame: 3 months post-curative radiotherapy]
  • DV and Ki parameters derived from direct and indirect Patlak reconstructions with IDIF and/or PBIF. [Time frame: 3 months post-curative radiotherapy]
  • Dates of imaging, dates of progression, dates of death and end of study dates [Time frame: 12 months post TEP-FDG LAVOF imaging]

Eligibility criteria

Inclusion criteria

  • 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
  • Having given consent for the end-of-treatment consultation

Exclusion criteria

  • Hypersensitivity to 18F-FDG or other excipients contained in the contrast agent
  • Pregnancy or breastfeeding
  • History of treated upper gastrointestinal tract cancer
  • Other histology
  • Incomplete RTE treatment regimen
  • Refusal to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Centre finistérien de radiothérapie et d'oncologie - site Clinique Pasteur — Brest
  • Centre finistérien de radiothérapie et d'oncologie - Site de l'hôpital La Cavale Blanche — Brest
  • CHU Brest — Brest

Identifiers

NCT: NCT07417605 · POLARIS - 29BRC24.0308

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗