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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Nice
RECRUITING
Nice
Contact Information
Primary
Micheline RAZZOUK-CADET, MD
razzouk-cadet.m@chu-nice.fr
+33492035671
Backup
Delphine DEL CONT
delcont.d@chu-nice.fr
Time Frame
Start Date: 2020-11-24
Estimated Completion Date: 2027-11
Participants
Target number of participants: 20
Treatments
Experimental: early research PET-CT
The patient will undergo an early research PET-CT after 2 cycles of anti-PD1 (PET1) between the baseline PET-CT and the PET-CT at 3 months of initiation of treatment
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov