Clinical trial NCT06467773: TSPO-PET/MRI in Surveillance of Neuroinflammation in the Central Nervous System
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Nervous System Diseases
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Jianmin Pharmaceutical Group Co., LTD.
First posted: 2024-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.)

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.


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

Primary outcomes:
measure: Changes in TSPO Radiotracer Uptake
timeFrame: 12 months
Secondary outcomes:
measure: Free Diffusing Water Fraction
timeFrame: 12 months
measure: Peripheral Levels of Pro-Inflammatory Cytokines
timeFrame: 12 months
measure: CSF Levels of Pro-Inflammatory Cytokines
timeFrame: 12 months
measure: CSF Levels of neural injury markers
timeFrame: 12 months
measure: MRI Correlation
timeFrame: 12 months
measure: Inflammatory Markers correlation
timeFrame: 12 months
measure: Neural injury markers correlation
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.