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

NCT06467773 | Recruiting

• 1 other identifier: PETinCNS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• Changes in TSPO Radiotracer Uptake

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

  12 months

Secondary Outcomes (7)

• Free Diffusing Water Fraction

  12 months

• Peripheral Levels of Pro-Inflammatory Cytokines

  12 months

• CSF Levels of Pro-Inflammatory Cytokines

  12 months

• CSF Levels of neural injury markers

  12 months

• MRI Correlation

  12 months

Study Arms (3)

ICVD

ischemic cerebrovascular diseases

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

Neurological Autoimmune Diseases

Multiple Sclerosis，Neuromyelitis Optica Spectrum Disorders and Autoimmune Encephalitis

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

other

other encephalomyelitis

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

Interventions

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

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

ICVD; Neurological Autoimmune Diseases; other

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosis with central nervous system diseases (lesions occurring in the brain or spinal cord, such as stroke, autoimmune encephalitis, neuromyelitis optica spectrum disorders, multiple sclerosis, etc.)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead
• Jianmin Pharmaceutical Group Co., LTD.: collaborator

Study Sites (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (5)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood, cerebrospinal fluid or feces

MeSH Terms

Conditions

Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Wei Wang, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luo-qi Zhou, MD

CONTACT

86-27-83663337; zhouluoqi@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, President of Tongji Hospita

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)