- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03741231
18FDG-PET in Patients With Melanoma or NSCLC Treated With Immunotherapy (IMMUNOPET)
18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Brest, France, 29609
- CHRU de Brest
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Landerneau, France
- CH de Landerneau
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Morlaix, France
- Centre Hospitalier de Morlaix
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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