Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06467773

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Chuan Qin, MD

SUB_INVESTIGATOR

Dai-shi Tian, MD

SUB_INVESTIGATOR

Jun Xiao, MD

SUB_INVESTIGATOR

Luo-qi Zhou, MD

CONTACT

[email protected]

86-27-83663337

Luo-qi Zhou, MD

SUB_INVESTIGATOR

Si-yuan Cheng, MD

SUB_INVESTIGATOR

Wei Wang, MD

PRINCIPAL_INVESTIGATOR

Xiao-hua Zhu, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Radiation

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

Primary outcomes

  1. Changes in TSPO Radiotracer Uptake

    Time frame: 12 months

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

Secondary outcomes

  1. Free Diffusing Water Fraction

    Time frame: 12 months

    Calculated using MR-DWI

  2. Peripheral Levels of Pro-Inflammatory Cytokines

    Time frame: 12 months

    Evaluated using blood samples, including IL-6, IL-4, IL-10, hs-CRP and PCT etc,al

  3. CSF Levels of Pro-Inflammatory Cytokines

    Time frame: 12 months

    Evaluated using cerebrospinal fluid, IL-6, IL-4, IL-10, hs-CRP and PCT etc, al

  4. CSF Levels of neural injury markers

    Time frame: 12 months

    Evaluated using cerebrospinal fluid, GFAP, NFL and sTREM2 etc, al

  5. MRI Correlation

    Time frame: 12 months

    Correlation of white matter lesion volume and MRI measures of white matter tract injury determined from DTI with measures of TSPO uptake

  6. Inflammatory Markers correlation

    Time frame: 12 months

    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 cerebrospinal fluid

  7. Neural injury markers correlation

    Time frame: 12 months

    Correlation of PET derived measures of TSPO uptake with neural injury markers ( GFAP, NFL and sTREM2) in the cerebrospinal fluid

Study contacts

Contact information is provided by the study sponsor or research team.

Luo-qi Zhou, MD

CONTACT

[email protected]

86-27-83663337

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • Jianmin Pharmaceutical Group Co., LTD.

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 21, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.