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

Sponsor

Center Eugene Marquis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05672082

Collaborator

(none)

Enrollment

Arm

21.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma	Drug: [18F]DPA-714	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: [18F]DPA-714 PET

Drug: [18F]DPA-714

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Center Eugene Marquis

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Center Eugene Marquis

ClinicalTrials.gov Identifier:

NCT05672082

Other Study ID Numbers:

2022-1-58-002

First Posted:

Jan 5, 2023

Last Update Posted:

Jan 5, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glioma

Study Results

No Results Posted as of Jan 5, 2023