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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06467773
Enrollment
100
Registered
2024-06-21
Start date
2024-07-01
Completion date
2029-12-30
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Diseases

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.

Interventions

RADIATIONRadiation: PET-MRI with [18F]-DPA-714

Radiation: PET-MRI with \[18F\]-DPA-714

Sponsors

Jianmin Pharmaceutical Group Co., LTD.
CollaboratorINDUSTRY
Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in TSPO Radiotracer Uptake12 monthsQuantify the regional neuroinflammatory load, measured as binding of PET tracer to TSPO.

Secondary

MeasureTime frameDescription
Peripheral Levels of Pro-Inflammatory Cytokines12 monthsEvaluated using blood samples, including IL-6, IL-4, IL-10, hs-CRP and PCT etc,al
CSF Levels of Pro-Inflammatory Cytokines12 monthsEvaluated using cerebrospinal fluid, IL-6, IL-4, IL-10, hs-CRP and PCT etc, al
CSF Levels of neural injury markers12 monthsEvaluated using cerebrospinal fluid, GFAP, NFL and sTREM2 etc, al
Free Diffusing Water Fraction12 monthsCalculated using MR-DWI
Inflammatory Markers correlation12 monthsCorrelation 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 correlation12 monthsCorrelation of PET derived measures of TSPO uptake with neural injury markers ( GFAP, NFL and sTREM2) in the cerebrospinal fluid
MRI Correlation12 monthsCorrelation of white matter lesion volume and MRI measures of white matter tract injury determined from DTI with measures of TSPO uptake

Countries

China

Contacts

Primary ContactLuo-qi Zhou, MD
zhouluoqi@tjh.tjmu.edu.cn86-27-83663337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026