PET/CT Whole-body Dynamic Acquisition at FDG to Metastatic Melanoma Under Immunotherapy (IMMUNOPET2)

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

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..

Study Overview

• Status: Recruiting
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Diagnostic test: value of 4D body-to-whole dynamic acquisition in FDG

• Study Type: Observational
• Enrollment (Estimated): 56

Contacts and Locations

• Study Contact: Name: Ronan ABGRAL, MD-PhD; Phone Number: +33 (0) 298223327; Email: ronan.abgral@chu-brest.fr
• Study Contact Backup: Name: Karim AMRANE, MD; Email: amranekarim@ymail.com

Study Locations

• France
  • Finistere
    • Brest, Finistere, France, 29200
      • Recruiting
      • Hospital University ff Brest
      • Contact: Ronan ABGRAL, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with metastatic melanoma treated with immune checkpoint inhibitors (ICI) and do 4D body-to-whole dynamic acquisition in FDG PET / CT to differentiate progression / pseudo-progression

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Ronan ABGRAL, MD-PhD, Nuclear Medecine

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2020
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 29BRC19.0194 (IMMUNO-PET2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No