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Clinical Trials/NCT06467773
NCT06467773
Recruiting
Not Applicable

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 site in 1 country100 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Nervous System Diseases
Sponsor
Tongji Hospital
Enrollment
100
Locations
1
Primary Endpoint
Changes in TSPO Radiotracer Uptake
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
December 30, 2029
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wei Wang

Professor of Neurology, President of Tongji Hospita

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Changes in TSPO Radiotracer Uptake

Time Frame: 12 months

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

Secondary Outcomes

  • 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)

Study Sites (1)

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