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Recruiting NCT06467773

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

Observational Central Nervous System Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation: PET-MRI with [18F]-DPA-714.
Who it may be relevant to
Registry conditions: Central Nervous System Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • Changes in TSPO Radiotracer Uptake [Time frame: 12 months]
Secondary outcome measures (7)
  • Free Diffusing Water Fraction [Time frame: 12 months]
  • Peripheral Levels of Pro-Inflammatory Cytokines [Time frame: 12 months]
  • CSF Levels of Pro-Inflammatory Cytokines [Time frame: 12 months]
  • CSF Levels of neural injury markers [Time frame: 12 months]
  • MRI Correlation [Time frame: 12 months]
  • Inflammatory Markers correlation [Time frame: 12 months]
  • Neural injury markers correlation [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and — Wuhan

Publications

  • Shi K, Tian DC, Li ZG, Ducruet AF, Lawton MT, Shi FD. Global brain inflammation in stroke. Lancet Neurol. 2019 Nov;18(11):1058-1066. doi: 10.1016/S1474-4422(19)30078-X. Epub 2019 Jul 8. PMID 31296369
  • Kwon HS, Koh SH. Neuroinflammation in neurodegenerative disorders: the roles of microglia and astrocytes. Transl Neurodegener. 2020 Nov 26;9(1):42. doi: 10.1186/s40035-020-00221-2. PMID 33239064
  • Voet S, Prinz M, van Loo G. Microglia in Central Nervous System Inflammation and Multiple Sclerosis Pathology. Trends Mol Med. 2019 Feb;25(2):112-123. doi: 10.1016/j.molmed.2018.11.005. Epub 2018 Dec 18. PMID 30578090
  • Kreisl WC, Kim MJ, Coughlin JM, Henter ID, Owen DR, Innis RB. PET imaging of neuroinflammation in neurological disorders. Lancet Neurol. 2020 Nov;19(11):940-950. doi: 10.1016/S1474-4422(20)30346-X. PMID 33098803
  • Zhang M, Meng H, Zhou Q, Chunyu H, He L, Meng H, Wang H, Wang Y, Sun C, Xi Y, Hai W, Huang Q, Li B, Chen S. Microglial Activation Imaging Using 18F-DPA-714 PET/MRI for Detecting Autoimmune Encephalitis. Radiology. 2024 Mar;310(3):e230397. doi: 10.1148/radiol.230397. PMID 38441089

Identifiers

NCT: NCT06467773 · PETinCNS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗