TSPO-PET/MRI in Surveillance of Neuroinflammation in the Central Nervous System
NCT Number: NCT06467773
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Central Nervous System Diseases
Interventions: RADIATION: Radiation: PET-MRI with [18F]-DPA-714
Sponsor: Tongji Hospital
Collaborators: Wuhan Jianmin DAPENG Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2029-12-30
Locations: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China

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.

Primary Outcome Measures: Changes in TSPO Radiotracer Uptake, Quantify the regional neuroinflammatory load, measured as binding of PET tracer to TSPO., 12 months
Secondary Outcome Measures: Free Diffusing Water Fraction, Calculated using MR-DWI, 12 months|Peripheral Levels of Pro-Inflammatory Cytokines, Evaluated using blood samples, including IL-6, IL-4, IL-10, hs-CRP and PCT etc,al, 12 months|CSF Levels of Pro-Inflammatory Cytokines, Evaluated using cerebrospinal fluid, IL-6, IL-4, IL-10, hs-CRP and PCT etc, al, 12 months|CSF Levels of neural injury markers, Evaluated using cerebrospinal fluid, GFAP, NFL and sTREM2 etc, al, 12 months|MRI Correlation, Correlation of white matter lesion volume and MRI measures of white matter tract injury determined from DTI with measures of TSPO uptake, 12 months|Inflammatory Markers correlation, 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, 12 months|Neural injury markers correlation, Correlation of PET derived measures of TSPO uptake with neural injury markers ( GFAP, NFL and sTREM2) in the cerebrospinal fluid, 12 months