PET/CT Whole-body Dynamic Acquisition at FDG to Metastatic Melanoma Under Immunotherapy

Study Overview
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Brief Summary
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The value of 4D body-to-whole dynamic acquisition in FDG PET / CT to differentiate progression / pseudo-progression during the first therapeutic assessment (PET1) of metastatic melanoma treated with immune checkpoint inhibitors (ICI)to predict the progression of the disease..

Official Title
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Interest in PET/CT Whole-body Dynamic Acquisition at FDG to Differentiate Progression/Pseudo Progression of Metastatic Melanoma Under Immunotherapy

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Diagnostic Test: value of 4D body-to-whole dynamic acquisition in FDG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient old ≥ 18 years With metastatic melanoma Treated with anti-PD1 : Nivolumab or Pembrolizumab or Combo IPI-Nivo Having formulated a non-opposition Exclusion Criteria: - Minor patient < 18 years Pregnancy or breastfeeding Other type of tumor than metastatic melanoma Non-eligibility for the examination Refusal of participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| value of 4D body-to-whole dynamic acquisition in FDG<br>differentiate pseudo-progression / progression during the first therapeutic assessment by FDG PET / CT (PET1) using data from the 4D whole-body dynamic acquisition, without having to re-evaluate closely. during a PET1 'this unconfirmed progression after 2 new treatment cures of immune checkpoint inhibitors in metastatic melanoma | Diagnostic Test: value of 4D body-to-whole dynamic acquisition in FDG<br>* differentiate pseudo-progression / progression during the first therapeutic assessment by FDG PET / CT (PET1) using data from the 4D whole-body dynamic acquisition, without having to re-evaluate closely. during a PET1 'this unconfirmed progression after 2 new treatment cures of ICI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Values of the Ki absorption coefficient resulting from a FDG PET / CT full-body 4D dynamic acquisition to differentiate the pseudo-progression / progression of metastatic melanoma treated with ICI |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the Ki lesion values derived from PET1 and the quantitative parameters resulting from PET0 histological specifications of the tumors (% PD-L1, T-CD8 infiltration, PTEN status) to differentiate pseudo-progression / progression. |  | 5 years | 
| Correlation between the Ki lesional values resulting from the 4D acquisition of the PET / CT from PET1 and PET0 the biological parameters (LDH, leucocytes, neutrophils) to differentiate pseudo-progression / progression |  | 5 years | 
| Correlation between the Ki lesion values resulting from the 4D acquisition of FDG PET / CT for PET1 and the quantitative parameters resulting from PET0 to differentiate pseudo-progression / progression |  | 5 years | 
| Correlation between lesional Ki values resulting from the 4D acquisition of FDG PET / CT for from PET1 and the quantitative parameters resulting from PET0 ICI- related adverse effect to differentiate pseudo-progression / progression |  | 5 years |