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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07417605

Acronym

POLARIS

Enrollment

180

Registered

2026-02-18

Start date

2026-04-13

Completion date

2029-06-13

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head & Neck Squamous Cell Carcinoma

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	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

Measure	Time frame
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

Countries

France

Contacts

CONTACTRonan ABGRAL, Pr

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

CONTACTJean-Christophe LECLERE, Dr

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

Outcome results