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临床试验/NCT06467773
NCT06467773招募中不适用

An Oberservational Study of Utility of TSPO-PET/MRI Using the Radiotracer ([18F]-DPA-714) in Surveillance of Neuroinflammation in the Central Nervous System

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Changes in TSPO Radiotracer Uptake

研究概览

简要总结

Central Nervous System (CNS) inflammation is an immune response activated in the brain and spinal cord by microglial cells and astrocytes, commonly occurring under conditions such as central nervous system ischemia, autoimmunity, infection, toxins, and trauma.

Microglial cells, as the innate immune cells of the central nervous system, are responsible for driving the inflammatory response and play a crucial role in sensing environmental changes, responding to harmful stimuli, and engulfing dead neurons. They also present antigens to T lymphocytes, mediating interactions between the peripheral immune system and the central nervous system. Factors released by neuronal cells can either promote or inhibit inflammation, and monitoring the level of inflammation driven by microglial cells is essential for the diagnosis and treatment of central nervous system diseases.

MRI is the primary imaging method for central nervous system inflammation, but it can be challenging to diagnose. PET/MR, a technology that integrates PET and MR imaging, provides high-quality diagnostic images and is valuable for the early detection, diagnosis, and assessment of central nervous system diseases. The radioactive ligand 18F-DPA-714 PET, targeting the translocation protein (TSPO), can visualize activated microglial cells, which may have a gain effect in detecting active central nervous system inflammation.

This study aims to explore the application of 18F-DPA-714 PET/MR in the early diagnosis, treatment evaluation, and prognosis of central nervous system inflammation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Clinical diagnosis of ischemic stroke, autoimmune ecephalitis, Neuromyelitis optica spectrum disorders, or multiple sclerosis, etc.al

排除标准

  • Claustrophobia
  • Metal Implants
  • Breast-feeding
  • Renal insufficiency (GFR < 60 mL/min/1.73m2)
  • Allergy or other contraindication to gadolinium-based MR contrast agent

结局指标

主要结局

Changes in TSPO Radiotracer Uptake

时间窗: 12 months

Quantify the regional neuroinflammatory load, measured as binding of PET tracer to TSPO.

次要结局

  • Inflammatory Markers correlation(12 months)
  • Neural injury markers correlation(12 months)
  • Free Diffusing Water Fraction(12 months)
  • Peripheral Levels of Pro-Inflammatory Cytokines(12 months)
  • CSF Levels of neural injury markers(12 months)
  • CSF Levels of Pro-Inflammatory Cytokines(12 months)
  • MRI Correlation(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Wang

Professor of Neurology, President of Tongji Hospita

Tongji Hospital

研究点 (1)

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