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

University Hospital, Brest1 site in 1 country56 target enrollmentJune 26, 2020

ConditionsMetastatic Melanoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Melanoma
Sponsor: University Hospital, Brest
Enrollment: 56
Locations: 1
Primary Endpoint: 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
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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..

Registry

clinicaltrials.gov

Start Date

June 26, 2020

End Date

June 26, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Brest

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 5 years

Secondary Outcomes

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 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 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)