2025-522768-33-00招募中2 期
Is [18F]-DPA-714 PET a good marker of neuroinflammation in autoimmune encephalitis? (EAI-714)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
Whole-brain [18F]-DPA-714 binding potential (BP) in autoimmune encephalitis patients compared to healthy controls.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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.
结局指标
主要结局
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).
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).
次要结局
- 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
研究者
Delphine VERNET
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (1)
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