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

Metastatic Melanoma Clinical Trial

— IMMUNOPET2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04272658
• Other study ID #: 29BRC19.0194 (IMMUNO-PET2)
• Status: Recruiting
• Start date: June 26, 2020
• Est. completion date: June 26, 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Brest
• Contact: Ronan ABGRAL, MD-PhD
• Phone: +33 (0) 298223327
• Email: ronan.abgral[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 26, 2026
• Est. primary completion date: June 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Diagnostic Test:
• 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 ICI

Locations

Country	Name	City	State
France	Hospital University ff Brest	Brest	Finistere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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