RecruitingNot ApplicableNCT03888950

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


Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

20 participants

Start Date

Nov 24, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a PET/CT scan done partway through immunotherapy treatment can help predict how well the therapy is working in people with advanced melanoma treated with anti-PD1 drugs (nivolumab or pembrolizumab). The goal is to find a way to identify earlier whether the treatment is effective or needs to be changed. **You may be eligible if...** - You are 18 or older - You have advanced (metastatic) melanoma confirmed by biopsy — cutaneous or unknown primary type - You are starting treatment with nivolumab or pembrolizumab - You have social insurance (required in France where this study is conducted) **You may NOT be eligible if...** - You have ocular (eye) or mucosal (inner lining) melanoma - You have uncontrolled diabetes or severe claustrophobia (PET scan contraindications) - You are HIV, hepatitis B, or hepatitis C positive - Your only tumors are very small (under 8 mm), except for lung nodules - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTFDG PET-CT

FDG PET/CT for oncological imaging of adult patients


Locations(1)

CHU de Nice

Nice, CHU de NICE, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03888950


Related Trials