NCT03888950 Interim FDG PET-CT in Melanoma Metastatic Patient's Treated by Anti-PD1 Therapy
| NCT ID | NCT03888950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Metastatic Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-11-24 |
| Primary Completion | 2022-11-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2020-11-24 with a primary completion date of 2022-11-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Micheline RAZZOUK-CADET, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Frequently Asked Questions
Who can join the NCT03888950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03888950 currently recruiting?
Yes, NCT03888950 is actively recruiting participants. Contact the research team at razzouk-cadet.m@chu-nice.fr for enrollment information.
Where is the NCT03888950 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT03888950 clinical trial?
NCT03888950 is sponsored by Centre Hospitalier Universitaire de Nice. The principal investigator is Micheline RAZZOUK-CADET, MD at Centre Hospitalier Universitaire de Nice. The trial plans to enroll 20 participants.
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