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. (POLARIS)

April 21, 2026 updated by: University Hospital, Brest
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post-curative radiotherapy

Secondary Outcome Measures

Outcome 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).
Time Frame: 3 months post-curative radiotherapy
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
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
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
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
12 months post TEP-FDG LAVOF imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Estimated)

June 13, 2029

Study Completion (Estimated)

June 13, 2029

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POLARIS - 29BRC24.0308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning two years and ending five years following the publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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