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NCT03741231 Clinical Trial

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

Melanoma Clinical Trial

— IMMUNOPET  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03741231
Other study ID # IMMUNOPET ( 29BRC17.0253).
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date June 30, 2018

Study information
Verified date March 2019
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Multicentric retrospective study

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest
France CH de LANDERNEAU Landerneau
France Centre Hospitalier de Morlaix Morlaix

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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 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
Secondary Study different criteria (RECIST, iRECIST, PERCIST and PECRIT) to predict PFS or OS Interpretation according to 4 criteria to predict response to immunotherapy up to 50 months
Secondary study the potential correlation between PET data and clinicobiological data correlation between adverse events (AE) due to immunotherapy described on PET data and AE detected on clinicobiological data up to 50 months
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