Is [18F]-DPA-714 PET a good marker of neuroinflammation in autoimmune encephalitis? (EAI-714)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Toulouse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

31 Mar 2026 → ongoing

Decision date (initial)

2025-12-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU de Toulouse dans le cadre de l’AAP Recherche & Innovation (ARI) 2024

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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

Secondary objectives 4

1. 1. Assess the percentage of patients with pathological [18F]-DPA-714 PET scans compared with controls.
2. . 2. Comparison of PET-detected neuroinflammation with conventional biomarkers (MRI, CSF analysis), at inclusion
3. 3. Relationship between [18F]-DPA-714 binding intensity and clinical severity, at inclusion.
4. 4. Exploratory analysis of concordance between PET binding localization and patient symptoms, at inclusion.

Conditions and MedDRA coding

autoimmune encephalitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 5

1. Pregnant women
2. contraindications to MRI
3. known allergic reaction to [18F]-DPA-714
4. legal protection measure
5. paraneoplastic syndrome following immune checkpoint inhibitor therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint will be the value of the «Binding Potential» (BP) of DPA-714 at the whole brain scale calculated by an automated clustering method in supervised cluster analysis (SVCA).

Secondary endpoints 5

1. The BPs of regions of interest will be compared between patients and controls.
2. The result of imaging [18F]-DPA-714 in PET will be, for each participant, dichotomized into 2: positive and negative. A result will be classified as "positive" if at least one region of interest has a BP greater than 2-DS compared to the average of control participants as done in the study by Zhang et al., 2024. The percentage of patients with a positive result will be calculated.
3. The results of other biomarkers conventionally used for the diagnosis of AIE will also be divided into 'positive' and 'negative'. Patients will be classified into positive/negative according to each biomarker to identify the most effective biomarker.
4. Finally, a linear regression analysis will be performed between the overall BP of patients and clinical severity scores
5. We will make a description of a possible concordance between the BP by region of interest and the presence of identified symptoms

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Toulouse

Sponsor organisation

Centre Hospitalier Universitaire De Toulouse

Address

2 Rue Viguerie

City

Toulouse

Postcode

31300

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

Delphine VERNET

Public contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

Delphine VERNET

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications