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).
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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