Interim FDG PET-CT in Melanoma Metastatic Patient's Treated by Anti-PD1 Therapy
Recruiting · NCT03888950 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Nice
View the official record on ClinicalTrials.gov →Interventions studied
FDG PET-CT
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Age less than 18 years,
- Patient with ocular or mucosal melanoma,
- Contraindication to PET CT examination: Severe claustrophobia, unbalanced diabetes (fasting hairy blood glucose ≥ 11 mmol),
- Patient with only metastatic lesions less than 8 mm in size, with the exception of pulmonary nodules,
- HIV and/or HCV (hepatitis C virus) and/or HBV (hepatitis B virus) positive serology, active autoimmune disease,
- Withdrawal of informed consent,
- Metastatic disease not confirmed histologically.
Where it is running
1 location listed.
- CHU de Nice - Nice, CHU de NICE, France