Metastatic Melanoma
Conditions
Brief summary
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..
Interventions
DIAGNOSTIC_TESTvalue of 4D body-to-whole dynamic acquisition in FDG
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
Sponsors
University Hospital, Brest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Contacts
Primary ContactRonan ABGRAL, MD-PhD
Backup ContactKarim AMRANE, MD
Outcome results
None listed