TSPO-PET/MRI in Surveillance of Neuroinflammation in the Central Nervous System

Recruiting

• Conditions: Central Nervous System Diseases

• Registration Number: NCT06467773
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-21
• Study Start: 2024-07-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08
• Primary Completion: 2029-06
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in TSPO Radiotracer Uptake	12 months	Quantify the regional neuroinflammatory load, measured as binding of PET tracer to TSPO.

Secondary Outcome Measures

Name	Time	Method
CSF Levels of Pro-Inflammatory Cytokines	12 months	Evaluated using cerebrospinal fluid, IL-6, IL-4, IL-10, hs-CRP and PCT etc, al
Inflammatory Markers correlation	12 months	Correlation of PET derived measures of TSPO uptake with inflammatory markers (IL-6, IL-4, IL-10, hs-CRP and PCT etc, al) in the blood or cerebrospinal fluid
Neural injury markers correlation	12 months	Correlation of PET derived measures of TSPO uptake with neural injury markers ( GFAP, NFL and sTREM2) in the cerebrospinal fluid
Free Diffusing Water Fraction	12 months	Calculated using MR-DWI
Peripheral Levels of Pro-Inflammatory Cytokines	12 months	Evaluated using blood samples, including IL-6, IL-4, IL-10, hs-CRP and PCT etc,al
CSF Levels of neural injury markers	12 months	Evaluated using cerebrospinal fluid, GFAP, NFL and sTREM2 etc, al
MRI Correlation	12 months	Correlation of white matter lesion volume and MRI measures of white matter tract injury determined from DTI with measures of TSPO uptake

Trial Locations

Locations (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China