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

NCT05672082 | Withdrawn

• 1 other identifier: 2022-1-58-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 tumor microenvironment

  [18F]DPA-714 PET performed up to 30 days before brain surgery

Study Arms (1)

[18F]DPA-714 PET

EXPERIMENTAL

Drug: [18F]DPA-714

Interventions

[18F]DPA-714 DRUG

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

[18F]DPA-714 PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center Eugene Marquis: lead

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Xavier PALARD NOVELLO, Dr

  Centre de lutte contre le cancer Eugène Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share