Head & Neck Squamous Cell CarcinomaPOLARISNCT07417605
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.
An observational study of Head & Neck Squamous Cell Carcinoma, run by University Hospital, Brest at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Squamous Cell Carcinoma
- How many people
- 180 participants
- Where
- 3 sitesFrance
- Study dates
- 13 Apr 2026to 13 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with radiotherapy for curative purposes for squamous cell carcinoma of the upper aerodigestive tract.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Centre finistérien de radiothérapie et d'oncologie - site Clinique Pasteur
Brest, 29200
Mohammed BOUCHEKOUA, +332 22 90 02 45, mbouchekoua@oncologie-brest.fr
- Not yet recruiting
Centre finistérien de radiothérapie et d'oncologie - Site de l'hôpital La Cavale Blanche
Brest, 29200
Mohammed BOUCHEKOUA, +332 22 90 02 45, mbouchekoua@oncologie-brest.fr
- Recruiting
CHU Brest
Brest, 29200
Jean-Christophe Leclere, Dr, +33229020291, jean-christophe.leclere@chu-brest.fr
About this study
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
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 months post-curative radiotherapy
Dynamic (standard Ki and DV) and static (SUVmax, SUVmean, SUVpeak, MTV, TLG, textural features) parameters in LAFOV FDG-PET.
Measured: 3 months post-curative radiotherapy
Ki and DV parameters in LAFOV FDG-PET and the occurrence of post-radiation toxicity
Measured: 3 months post-curative radiotherapy
DV and Ki parameters derived from direct and indirect Patlak reconstructions with IDIF and/or PBIF.
Measured: 3 months post-curative radiotherapy
Dates of imaging, dates of progression, dates of death and end of study dates
Measured: 12 months post TEP-FDG LAVOF imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start13 Apr 2026
- Primary completion13 Jun 2029 (estimated)
- Study completion13 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417605
- Sponsor's protocol ID
- POLARIS - 29BRC24.0308
- Acronym
- POLARIS
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07417605
- Acronym / sponsor ID
- POLARIS / POLARIS - 29BRC24.0308
- Conditions
- Head & Neck Squamous Cell Carcinoma
- Keywords
- 4D dynamic analysis, post-radical inflammation, squamous cell carcinomas, FDG-PET LAFOV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 13 Jun 2029 (estimated)
- Study completion
- 13 Jun 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with radiotherapy for curative purposes for squamous cell carcinoma of the upper aerodigestive tract.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head & Neck Squamous Cell Carcinoma, run by University Hospital, Brest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronan ABGRAL, Pr (+332 98 22 30 69, ronan.abgral@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.