4D dynamic LAFOV FDG-PET to tell leftover cancer from post-radiation inflammation in head and neck squamous cell carcinoma
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.
This study will test whether a 4D dynamic long‑axial‑field‑of‑view FDG‑PET scan can tell remaining head and neck squamous cell cancer from normal post‑radiation inflammation in adults about three months after finishing curative radiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Brest) |
| Trial ID | NCT07417605 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational imaging study enrolling adults with head and neck squamous cell carcinoma who completed curative external radiotherapy. Participants undergo a 4D dynamic long‑axial‑field‑of‑view FDG‑PET acquisition at the routine three‑month post‑treatment therapeutic assessment. Dynamic PET data will be analyzed to distinguish residual viable tumor from post‑radiation inflammatory changes using kinetic/temporal imaging parameters. Imaging results will be compared with clinical follow‑up and, when available, biopsy or additional imaging to determine diagnostic performance.
Who should consider this trial
Good fit: Adults (≥18 years) with confirmed head and neck squamous cell carcinoma who completed curative external radiotherapy and are scheduled for a three‑month therapeutic FDG‑PET evaluation and can consent to the scan are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have hypersensitivity to 18F‑FDG, have non‑squamous histology, did not complete the curative radiotherapy regimen, or refuse participation are not expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce unnecessary biopsies and delays by improving accuracy in telling residual tumor from post‑radiation inflammation.
How similar studies have performed: Prior smaller studies of dynamic FDG‑PET have shown promise in separating inflammation from tumor, but the use of 4D long‑axial‑field‑of‑view PET for this purpose is relatively new and less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brest
- CHU Brest — Brest, France (Recruiting)
Study contacts
- Study coordinator: Ronan ABGRAL, Pr
- Email: ronan.abgral@chu-brest.fr
- Phone: +332 98 22 30 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.