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

May 2, 2019 updated by: University Hospital, Brest

18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy

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

Study Overview

Status

Completed

Conditions

Detailed Description

Study EFS in patients with melanoma or NSCLC treated by immunotherapy (anti CTLA4 or anti PDL1) and performed18FDG PET

Multicentric retrospective study

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Brest, France, 29609
    - CHRU de Brest
  - Landerneau, France
    - CH de Landerneau
  - Morlaix, France
    - Centre Hospitalier de Morlaix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

age under 18 years old
refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: up to 50 months	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: up to 50 months	From date of initiation of treatment until the date of death related to 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
Study different criteria (RECIST, iRECIST, PERCIST and PECRIT) to predict PFS or OS Time Frame: up to 50 months	Interpretation according to 4 criteria to predict response to immunotherapy	up to 50 months
study the potential correlation between PET data and clinicobiological data Time Frame: up to 50 months	correlation between adverse events (AE) due to immunotherapy described on PET data and AE detected on clinicobiological data	up to 50 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

November 12, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

IMMUNOPET ( 29BRC17.0253).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.