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

Central Nervous System Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467773
• Other study ID #: PETinCNS
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 30, 2029

Study information

• Verified date: June 2024
• Source: Tongji Hospital
• Contact: Luo-qi Zhou, MD
• Phone: 86-27-83663337
• Email: zhouluoqi[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 CNS ischemia, autoimmunity, infection, toxins, and trauma.

Microglial cells, as the innate immune cells of the CNS, 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 CNS. 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 CNS diseases.

MRI is the primary imaging method for CNS 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 CNS 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 CNS inflammation.

This study aims to explore the application of 18F-DPA-714 PET/MR in the early diagnosis, treatment evaluation, and prognosis of CNS inflammation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2029
• Est. primary completion date: June 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	Wuhan Jianmin DAPENG Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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/rad — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in TSPO Radiotracer Uptake	Quantify the regional neuroinflammatory load, measured as binding of PET tracer to TSPO.	12 months
Secondary	Free Diffusing Water Fraction	Calculated using MR-DWI	12 months
Secondary	Peripheral Levels of Pro-Inflammatory Cytokines	Evaluated using blood samples, including IL-6, IL-4, IL-10, hs-CRP and PCT etc,al	12 months
Secondary	CSF Levels of Pro-Inflammatory Cytokines	Evaluated using CSF, IL-6, IL-4, IL-10, hs-CRP and PCT etc, al	12 months
Secondary	CSF Levels of neural injury markers	Evaluated using CSF, GFAP, NFL and sTREM2 etc, al	12 months
Secondary	MRI Correlation	Correlation of white matter lesion volume and MRI measures of white matter tract injury determined from DTI with measures of TSPO uptake	12 months
Secondary	Inflammatory Markers correlation	Correlation 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 CSF	12 months
Secondary	Neural injury markers correlation	Correlation of PET derived measures of TSPO uptake with neural injury markers ( GFAP, NFL and sTREM2) in the CSF	12 months