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Not Yet RecruitingNCT07488117

Is [18F]-DPA-714 PET a Good Marker of Neuroinflammation in Autoimmune Encephalitis?

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

This study aims to evaluate the effectiveness of \[18F\]-DPA-714 PET imaging in detecting neuroimmune activity in patients with autoimmune encephalitis (AE). The primary objective is to compare \[18F\]-DPA-714 binding in AE patients to healthy controls.

Detailed description

Autoimmune encephalitis (AIE) constitutes a heterogeneous group of rare diseases affecting the central nervous system. They are distinguished by the presence of different antibody types and clinical manifestations. The diagnosis is inherently challenging due to the heterogeneity of symptoms, yet it is of paramount importance for the expeditious initiation of treatment. The current diagnostic criteria, established in 2016, define AIS as follows: possible, definite and seronegative. However, these criteria have limitations in terms of sensitivity and specificity. Furthermore, the diagnostic tools that are typically employed to detect inflammatory abnormalities in the central nervous system (brain MRI and analysis of CSF) are frequently inadequate in this condition. Positron emission tomography (PET) imaging targeting the 18-kDa translocator protein (TSPO) is emerging as a promising approach for the in vivo assessment of neuro-immune activity in EAI. The objective of the proposed research project is to examine neuro-immune activity on PET imaging at the onset of EAI. The procedure involves a 60-minute dynamic PET scan immediately after \[18F\]-DPA-714 injection. Patients will undergo clinical evaluation, MRI, and lumbar puncture as part of their standard care. Follow-up will include analysis of PET images, comparison with healthy controls, and comparison between PET results and conventional biomarkers (MRI, CSF analysis).

Conditions

Interventions

TypeNameDescription
OTHERTEP with radioligand EAI 71460-minutes \[18F\]-DPA-714 PET imaging

Timeline

Start date
2026-03-01
Primary completion
2026-06-01
Completion
2028-01-01
First posted
2026-03-23
Last updated
2026-03-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07488117. Inclusion in this directory is not an endorsement.