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

NCT04272658 | Recruiting DMC FDA Device

• 1 other identifier: 29BRC19.0194 (IMMUNO-PET2)
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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..

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

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

Interventions

value of 4D body-to-whole dynamic acquisition in FDG DIAGNOSTIC_TEST

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

value of 4D body-to-whole dynamic acquisition in FDG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient old ≥ 18 years
• With metastatic melanoma
• Treated with anti-PD1 : Nivolumab or Pembrolizumab or Combo IPI-Nivo
• Having formulated a non-opposition

You may not qualify if:

• \- Minor patient \< 18 years
• Pregnancy or breastfeeding
• Other type of tumor than metastatic melanoma
• Non-eligibility for the examination
• Refusal of participation

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Hospital University ff Brest

Brest, Finistere, 29200, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ronan ABGRAL, MD-PhD

  Nuclear Medecine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronan ABGRAL, MD-PhD

CONTACT

+33 (0) 298223327; ronan.abgral@chu-brest.fr

Karim AMRANE, MD

CONTACT

amranekarim@ymail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 17, 2020
• Study Start: June 26, 2020
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: June 26, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)