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

NCT ID: NCT06467773

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2029-12-30

Brief Summary

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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

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Conditions

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Central Nervous System Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICVD

ischemic cerebrovascular diseases

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

Intervention Type RADIATION

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

Neurological Autoimmune Diseases

Multiple Sclerosis,Neuromyelitis Optica Spectrum Disorders and Autoimmune Encephalitis

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

Intervention Type RADIATION

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

other

other encephalomyelitis

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

Intervention Type RADIATION

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

Interventions

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

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jianmin Pharmaceutical Group Co., LTD.

INDUSTRY

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Wang

Professor of Neurology, President of Tongji Hospita

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luo-qi Zhou, MD

Role: CONTACT

86-27-83663337

Facility Contacts

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Luo-qi Zhou, MD

Role: primary

86-27-83663337

References

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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.

Reference Type RESULT
PMID: 31296369 (View on PubMed)

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.

Reference Type RESULT
PMID: 33239064 (View on PubMed)

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.

Reference Type RESULT
PMID: 30578090 (View on PubMed)

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.

Reference Type RESULT
PMID: 33098803 (View on PubMed)

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.

Reference Type RESULT
PMID: 38441089 (View on PubMed)

Other Identifiers

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PETinCNS

Identifier Type: -

Identifier Source: org_study_id

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