Tests an early PET scan to check melanoma response to immunotherapy
Tests a PET-CT scan after two treatment cycles in adults with advanced melanoma.
Plain-language title generated from the registry record
Registry title: Interim FDG PET-CT in Melanoma Metastatic Patient's Treated by Anti-PD1 Therapy
Key facts
- Where
- Nice, FranceSee the site
Where in France
- CHU de NiceNice, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Nice
- Trial code
- NCT03888950
- Record updated
- 19 March 2025
- Original description
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.Read full original descriptionShow less
Early Response Assessment With Interim FDG PET-CT Imaging in Patients With Advanced Melanoma Treated by Immune Checkpoint Inhibitors Therapy Anti-PD1
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.
Inclusion: Age greater than or equal to 18 years,; Patient with advanced melanoma proved histologically, not BRAF mutated, BRAFV600 mutated and wild mutated, cutaneous or unknown primary melanoma having an indication of treatment with anti-PD-1 immunotherapy by nivolumab or Pembrolizumab,; Patient having social insurance,; Patient who has signed informed consent.
Exclusion: HIV and/or HCV (hepatitis C virus) and/or HBV (hepatitis B virus) positive serology, active autoimmune disease,; Metastatic disease not confirmed histologically; Contraindication to PET CT examination: Severe claustrophobia, unbalanced diabetes (fasting hairy blood glucose ≥ 11 mmol),; Age less than 18 years,; Patient with ocular or mucosal melanoma,; Patient with only metastatic lesions less than 8 mm in size, with the exception of pulmonary nodules,; Withdrawal of informed consent,.