18FDG-PET in Patients With Melanoma or NSCLC Treated With Immunotherapy

NCT03741231 | Completed

• 1 other identifier: IMMUNOPET ( 29BRC17.0253).
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy.

Conditions

Melanoma; NSCLC; Positron-Emission Tomography; Immunotherapy; 18F-FDG

Keywords

melanoma; NSCLC; FDG; PET; immunotherapy

Outcome Measures

Primary Outcomes (1)

• measure of progression free survival (obtained by the delay between the date of initiation of immunotherapy until the date of first documented progression disease in patients with melanoma or NSCLC treated by immunotherapy

  From date of initiation of treatment until the date of first documented progression disease according to different criteria in interim PET/CT 1. 18F-FDG PET/CT imaging was performed prior to (18F-FDG PET/CT 0) and 14 weeks after ICI onset (18F-FDG PET/CT 1). Assessment of patient response to treatment was done according to RECIST1.1, iRECIST, PERCIST and PECRIT criteria.

  up to 50 months

Secondary Outcomes (3)

• measure of overall survival (obtained by the delay between the date of initiation of immunotherapy until the date of death related to disease in patients with melanoma or NSCLC treated by immunotherapy

  up to 50 months

• Study different criteria (RECIST, iRECIST, PERCIST and PECRIT) to predict PFS or OS

  up to 50 months

• study the potential correlation between PET data and clinicobiological data

  up to 50 months

Eligibility Criteria

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

Study Population

70 patients (50 patients with melanoma and 20 patients with NSCLC)

You may qualify if:

• patients treated for melanoma or NSCLC with immunotherapy (anti CTLA4 or antiPDL1)
• patients treated in Brest, Morlaix, Landerneau hospital
• patients performed FDG PET
• no opposition to study

You may not qualify if:

• age under 18 years old
• refusal to participate

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (3)

CHRU de Brest

Brest, 29609, France

Location

CH de LANDERNEAU

Landerneau, France

Location

Centre Hospitalier de Morlaix

Morlaix, France

Location

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 Design

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

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: November 14, 2018
• Study Start: March 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 6, 2019

Record last verified: 2019-03

Locations

FR (3)