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NCT Number: 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.

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.

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Key information

Conditions

Head & Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brest, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: 3 months post-curative radiotherapy

    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

  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

  5. Dates of imaging, dates of progression, dates of death and end of study dates

    Time frame: 12 months post TEP-FDG LAVOF imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Christophe LECLERE, Dr

CONTACT

[email protected]

+332 98 22 02 91

Ronan ABGRAL, Pr

CONTACT

[email protected]

+332 98 22 30 69

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: POLARIS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 18, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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