NCT07488117

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
17mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Jan 2028

First Submitted

Initial submission to the registry

March 10, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

March 10, 2026

Last Update Submit

May 6, 2026

Conditions

Autoimmune Encephalitis (AE)

Outcome Measures

Primary Outcomes (1)

  • binding potential (BP) in AE patients

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

    Baseline

Study Arms (2)

patients with Autoimmune encephalitis

EXPERIMENTAL

patients with Autoimmune encephalitis

Other: TEP with radioligand EAI 714

control

EXPERIMENTAL

control

Other: TEP with radioligand EAI 714

Interventions

TEP with radioligand EAI 714OTHER

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

controlpatients with Autoimmune encephalitis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Nervous System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Marie Rafiq, MD

CONTACT

+33 561779491rafiq.m@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 23, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations

FR(1)