Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG PET-CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- early research PET-CT
- description
- 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
- interventionNames
- Diagnostic Test: FDG PET-CT
Primary outcomes (3)
- measure
- Quantifying changes in FDG uptake according to PERCIST criteria:Single-lesion analysis
- timeFrame
- Before the start of anti-PD1 treatment (PET0)(day 0), after 2 cycles of anti-PD1 (PET1) (between day 21 and day 31) and after 3 months of initiation of treatment(PET2)
- description
- -Single-lesion analysis: by measuring % change in SULpeak of the one lesion with the highest SUL on PET0 and PET1 and PET2 (not necessarily the same lesion),
- measure
- Quantifying changes in FDG uptake according to PERCIST criteria: Five lesion analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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