ClinicalTrials.gg
RecruitingNCT07417605POLARISUpdated Jul 13, 2026

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 in Head & Neck Squamous Cell Carcinoma, sponsored by University Hospital, Brest. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by University Hospital, Brest · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 215 studies in Squamous Cell Carcinoma of Head and Neck with a site in France — 46 open to participants now, 80 under way, 20 of them phase 3. Squamous Cell Carcinoma of Head and Neck · France.

Planned enrollment
6th of 17
180 · median 140
Started
2026
with 8 others
Observational
17 of 215
4 open now
Primary completion
2029-06
later than 62 of 79 live
Registered
211th of 215
by date

Among the 215 studies in Squamous Cell Carcinoma of Head and Neck with a site in France, this one is the 6th largest by planned enrollment of the 17 observational ones, is one of 9 that started in 2026, is one of 17 observational ones, reaches primary completion later than 62 of the 79 other live ones, and was the 211th registered.

By phase

215 studies; the count open now beside each. This study's row is marked.

Phase 255 · 7 open
Phase 343 · 8 open
Phase 137 · 7 open
No phase32 · 10 open
Phase 1/225 · 8 open
Observationalthis study17 · 4 open
Phase 2/36 · 2 open

By the year they started

First in 1994; this study’s year is marked. 9 started in 2026.

Size and results

Median enrollment 131 across the 197 interventional studies, 140 across the 17 observational. Of the 127 that completed or were terminated, 43 (34%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 215 studies in Squamous Cell Carcinoma of Head and Neck with a site in France, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Head & Neck Squamous Cell Carcinoma

Keywords

  • 4D dynamic analysis
  • post-radical inflammation
  • squamous cell carcinomas
  • FDG-PET LAFOV
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • to 18F-FDG or other contained in the contrast agent
  • Pregnancy or breastfeeding
  • History of treated upper gastrointestinal tract cancer
  • Other histology
  • Incomplete RTE treatment regimen
  • Refusal to participate
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 3 months post-curative radiotherapy

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

07

Study locations

1 of 3 sites recruiting
  • Centre finistérien de radiothérapie et d'oncologie - site Clinique Pasteur
    Brest, 29200, France
    Not yet recruiting
  • Centre finistérien de radiothérapie et d'oncologie - Site de l'hôpital La Cavale Blanche
    Brest, 29200, France
    Not yet recruiting
  • CHU Brest
    Brest, 29200, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jun 2029, 38 months after the start.

Of 108 non-industry observational studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 132. This study's planned 38 months is below that.

Counting every sponsor, half of 118 studies reached it within 81 months; a quarter within 29 and three quarters within 132.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2026
First posted
Feb 18, 2026
StartActual
Apr 13, 2026
Primary completionEst.
Jun 13, 2029
CompletionEst.
Jun 13, 2029
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07417605
Responsible party
Sponsor
First posted
Feb 18, 2026
Start date
Apr 13, 2026
Primary completion
Jun 13, 2029 (estimated)
Completion
Jun 13, 2029 (estimated)
Last update
Jul 13, 2026

Study contacts

Ronan ABGRAL, Pr
Contact
ronan.abgral@chu-brest.fr
+332 98 22 30 69
Jean-Christophe LECLERE, Dr
Contact
jean-christophe.leclere@chu-brest.fr
+332 98 22 02 91

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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