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

February 6, 2024 updated by: Center Eugene Marquis

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]DPA-714 PET
Drug: [18F]DPA-714
Participant received one injection of 200 MBq of [18F]DPA-714

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performances of [18F]DPA-714 PET for glioma grading obtained by stereotactic biopsies of glioma
Time Frame: [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
[18F]DPA-714 PET performed up to 30 days before brain surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of [18F]DPA-714 PET quantitative parameters with anatomopathological assessment of the surgery specimen
Time Frame: [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
[18F]DPA-714 PET performed up to 30 days before brain surgery
Comparison of [18F]DPA-714 PET quantitative parameters with tumor microenvironment
Time Frame: [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
[18F]DPA-714 PET performed up to 30 days before brain surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Xavier PALARD NOVELLO, Dr, Centre de lutte contre le cancer Eugène Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1-58-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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