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RECRUITINGINTERVENTIONAL

Interim FDG PET-CT in Melanoma Metastatic Patient's Treated by Anti-PD1 Therapy

Early Response Assessment With Interim FDG PET-CT Imaging in Patients With Advanced Melanoma Treated by Immune Checkpoint Inhibitors Therapy Anti-PD1

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body), - Withdrawal of willing to sign a consent form, - Metastatic disease not confirmed histologically. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIAGNOSTIC_TEST

FDG PET-CT

FDG PET/CT for oncological imaging of adult patients

Locations (1)

CHU de Nice
Nice, CHU de NICE, France