Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03888950

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

Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-19

20

Participants Needed

1

Research Sites

361 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 18 years
  • Advanced melanoma confirmed by tissue testing, including BRAF mutated or wild-type, cutaneous or unknown primary melanoma
  • Indication for treatment with anti-PD-1 immunotherapy (nivolumab or pembrolizumab)
  • Patient has social insurance
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Diagnosis of ocular or mucosal melanoma
  • Contraindications to PET CT such as severe claustrophobia or uncontrolled diabetes (fasting blood glucose ≥ 11 mmol)
  • Only metastatic lesions smaller than 8 mm (except pulmonary nodules)
  • Positive for HIV, hepatitis B virus, or hepatitis C virus
  • Active autoimmune disease
  • Withdrawal of informed consent
  • Metastatic disease not confirmed by tissue testing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Nice

Nice, CHU de NICE, France, 06003

Actively Recruiting

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Research Team

M

Micheline RAZZOUK-CADET, MD

CONTACT

D

Delphine DEL CONT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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