Actively Recruiting
Interim FDG PET-CT in Melanoma Metastatic Patient's Treated by Anti-PD1 Therapy
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-19
20
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess whether FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET-CT could be an early predictive method of therapeutic response to anti-PD-1 immunotherapy in metastatic melanoma after 2 cycles of ANTI-PD1. 20 patients will be enrolled and undergo three PET/CT scans: a baseline PET-CT, an early research PET-CT after 2 cycles of anti-PD1 (PET1) and a PET-CT at 3 months of initiation of treatment. Treatment response on FDG PET-CT will be assessed according to PERCIST criteria.
CONDITIONS
Official Title
Interim FDG PET-CT in Melanoma Metastatic Patient's Treated by Anti-PD1 Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 18 years
- Advanced melanoma confirmed by tissue testing, including BRAF mutated or wild-type, cutaneous or unknown primary melanoma
- Indication for treatment with anti-PD-1 immunotherapy (nivolumab or pembrolizumab)
- Patient has social insurance
- Signed informed consent
You will not qualify if you...
- Age less than 18 years
- Diagnosis of ocular or mucosal melanoma
- Contraindications to PET CT such as severe claustrophobia or uncontrolled diabetes (fasting blood glucose ≥ 11 mmol)
- Only metastatic lesions smaller than 8 mm (except pulmonary nodules)
- Positive for HIV, hepatitis B virus, or hepatitis C virus
- Active autoimmune disease
- Withdrawal of informed consent
- Metastatic disease not confirmed by tissue testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de Nice
Nice, CHU de NICE, France, 06003
Actively Recruiting
Research Team
M
Micheline RAZZOUK-CADET, MD
CONTACT
D
Delphine DEL CONT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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