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

Not Applicable

Withdrawn

• Conditions: Glioma
• Interventions: Drug: [18F]DPA-714

• Registration Number: NCT05672082
• Lead Sponsor: Center Eugene Marquis

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-05
• Study Start: 2023-10-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]DPA-714 PET	[18F]DPA-714	-

Primary Outcome Measures

Name	Time	Method
Diagnostic performances of [18F]DPA-714 PET for glioma grading obtained by stereotactic biopsies of glioma	[18F]DPA-714 PET performed up to 30 days before brain surgery	Sensitivity and specificity of \[18F\]DPA-714 PET using anatomopathological assessment of biopsies as gold standard

Secondary Outcome Measures

Name	Time	Method
Comparison of [18F]DPA-714 PET quantitative parameters with anatomopathological assessment of the surgery specimen	[18F]DPA-714 PET performed up to 30 days before brain surgery	Comparison of \[18F\]DPA-714 PET quantitative parameters with the histological types of gliomas, with the IDH1-mutational status, and the 1p19q codeletion status
Comparison of [18F]DPA-714 PET quantitative parameters with tumor microenvironment	[18F]DPA-714 PET performed up to 30 days before brain surgery	Comparison of \[18F\]DPA-714 PET quantitative parameters with the frequency and phenotype of tumor microenvironment different glioma-associated cells