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临床试验/NCT07488117
NCT07488117招募中2 期

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

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月31日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
40
试验地点
1
主要终点
binding potential (BP) in AE patients

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

patients with Autoimmune encephalitis

Experimental

patients with Autoimmune encephalitis

干预措施: TEP with radioligand EAI 714 (Other)

control

Experimental

control

干预措施: TEP with radioligand EAI 714 (Other)

结局指标

主要结局

binding potential (BP) in AE patients

时间窗: Baseline

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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