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

Recruiting

• Conditions: Metastatic Melanoma
• Interventions: Diagnostic Test: value of 4D body-to-whole dynamic acquisition in FDG

• Registration Number: NCT04272658
• Lead Sponsor: University Hospital, Brest

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..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Study Start: 2020-06-26
• Status Verified: 2023-12
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2026-06-26
• Study Completion: 2026-06-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
value of 4D body-to-whole dynamic acquisition in FDG	value 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 immune checkpoint inhibitors in metastatic melanoma

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital University ff Brest; 🇫🇷 Brest, Finistere, France