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

RECRUITINGN/ASponsored by Centre Hospitalier Universitaire de Nice
Actively Recruiting
PhaseN/A
SponsorCentre Hospitalier Universitaire de Nice
Started2020-11-24
Est. completion2022-11-24
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerMetastatic Melanoma

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