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NCT Number: NCT07488117

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital

Toulouse, France

Location status: Recruiting

Location contact

Marie RAFIQ, MD

CONTACT

[email protected]

Marie rafiq, MD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEP with radioligand EAI 714

Other

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

Primary outcomes

  1. binding potential (BP) in AE patients

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Rafiq, MD

CONTACT

[email protected]

+33 561779491

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: EAI-714

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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