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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522768-33-00
Acronym
RC31/24-0569
Enrollment
20
Registered
2025-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

autoimmune encephalitis

Brief summary

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).

Detailed description

The BPs of regions of interest will be compared between patients and controls., 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., 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., Finally, a linear regression analysis will be performed between the overall BP of patients and clinical severity scores, We will make a description of a possible concordance between the BP by region of interest and the presence of identified symptoms

Interventions

Sponsors

Centre Hospitalier Universitaire De Toulouse
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
The BPs of regions of interest will be compared between patients and controls., 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., 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., Finally, a linear regression analysis will be performed between the overall BP of patients and clinical severity scores, We will make a description of a possible concordance between the BP by region of interest and the presence of identified symptoms

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026