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NCT05672082 Clinical Trial

Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma.

Glioma Clinical Trial

— INFLAGLI  

Official title:
Contribution of [18F]DPA-714 PET for Grading and Exploration of the Inflammatory Microenvironment of Glioma, a Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05672082
Other study ID # 2022-1-58-002
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date April 1, 2025

Study information
Verified date February 2024
Source Center Eugene Marquis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The 18-kDa translocator protein (TSPO) is a mitochondrial protein that is weakly expressed in the healthy brain. However, there is an increase in the expression of TSPO in glial tumors. It is even associated with a higher malignancy and a shorter survival of patients. Among the different TSPO ligands, the most commonly used tracers in PET imaging are [18F]DPA-714 and 18F-GE180. We hypothesize that [18F]DPA-714 PET could improve the current performance for tumor grade definition in vivo, which is a major issue for the therapeutic management of gliomas.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age greater than or equal to 18 years - Suspicion of an operable diffuse glioma - Written informed consent (signed) - Affiliated or beneficiary of a social security plan Exclusion Criteria: - Suspicion of grade I glioma - Surgical urgency (less than 8 days between the suspected diagnosis and surgery) - Pregnant or breastfeeding woman - Persons deprived of liberty or under guardianship - Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• [18F]DPA-714
Participant received one injection of 200 MBq of [18F]DPA-714

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Center Eugene Marquis

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic performances of [18F]DPA-714 PET for glioma grading obtained by stereotactic biopsies of glioma Sensitivity and specificity of [18F]DPA-714 PET using anatomopathological assessment of biopsies as gold standard [18F]DPA-714 PET performed up to 30 days before brain surgery
Secondary Comparison of [18F]DPA-714 PET quantitative parameters with anatomopathological assessment of the surgery specimen Comparison of [18F]DPA-714 PET quantitative parameters with the histological types of gliomas, with the IDH1-mutational status, and the 1p19q codeletion status [18F]DPA-714 PET performed up to 30 days before brain surgery
Secondary Comparison of [18F]DPA-714 PET quantitative parameters with tumor microenvironment Comparison of [18F]DPA-714 PET quantitative parameters with the frequency and phenotype of tumor microenvironment different glioma-associated cells [18F]DPA-714 PET performed up to 30 days before brain surgery
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