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.

NCT07417605 | Recruiting

• 1 other identifier: POLARIS - 29BRC24.0308
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head & Neck Squamous Cell Carcinoma

Keywords

4D dynamic analysis; post-radical inflammation; squamous cell carcinomas; FDG-PET LAFOV

Outcome Measures

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.

  3 months post-curative radiotherapy

Secondary Outcomes (5)

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

  3 months post-curative radiotherapy

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

  3 months post-curative radiotherapy

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

  3 months post-curative radiotherapy

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

  3 months post-curative radiotherapy

• Dates of imaging, dates of progression, dates of death and end of study dates

  12 months post TEP-FDG LAVOF imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated with radiotherapy for curative purposes for squamous cell carcinoma of the upper aerodigestive tract.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU Brest

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ronan ABGRAL, Pr

CONTACT

+332 98 22 30 69; ronan.abgral@chu-brest.fr

Jean-Christophe LECLERE, Dr

CONTACT

+332 98 22 02 91; jean-christophe.leclere@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): June 13, 2029
• Study Completion (Estimated): June 13, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning two years and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)