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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07488117
Acronym
EAI-714
Enrollment
40
Registered
2026-03-23
Start date
2026-03-31
Completion date
2028-01-01
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Encephalitis (AE)

Brief 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).

Interventions

OTHERTEP with radioligand EAI 714

60-minutes \[18F\]-DPA-714 PET imaging

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

The diagnostic is made with a radioligand (EAI 714) during the TEP This is the Drug for the study, But the aim of the study is diagnostic

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-80 years; * meeting clinical criteria for "possible" AE with identified antibodies; * newly diagnosed with symptoms \<6 months; * no second-line immunosuppressive treatment; * high or mixed TSPO binding affinity phenotype.

Exclusion criteria

* Pregnant women; * contraindications to MRI; * known allergic reaction to \[18F\]-DPA-714; legal protection measure; * paraneoplastic syndrome following immune checkpoint inhibitor therapy.

Design outcomes

Primary

MeasureTime frameDescription
binding potential (BP) in AE patientsBaselineWhole-brain \[18F\]-DPA-714 binding potential (BP) in AE patients compared to healthy controls.

Countries

France

Contacts

CONTACTMarie Rafiq, MD
rafiq.m@chu-toulouse.fr+33 561779491

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026