Central Nervous System DiseasesNCT06467773
TSPO-PET/MRI in Surveillance of Neuroinflammation in the Central Nervous System
An observational study of Central Nervous System Diseases, run by Tongji Hospital at 1 site in China.
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 central nervous system ischemia, autoimmunity, infection, toxins, and trauma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System Diseases
- What is being tested?
- Radiation: PET-MRI with [18F]-DPA-714
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.)
Who may be able to join
- -Clinical diagnosis of ischemic stroke, autoimmune ecephalitis, Neuromyelitis optica spectrum disorders, or multiple sclerosis, etc.al
Who cannot join
- Claustrophobia
- Metal Implants
- Pregancy
- Breast-feeding
- Renal insufficiency (GFR < 60 mL/min/1.73m2)
- Allergy or other contraindication to gadolinium-based MR contrast agent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Luo-qi Zhou, MD, 86-27-83663337, zhouluoqi@tjh.tjmu.edu.cn
Wei Wang, MD
About this study
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
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.
Read more
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
- Being tested
- Radiation: PET-MRI with [18F]-DPA-714
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: PET-MRI with [18F]-DPA-714Radiation
Radiation: PET-MRI with [18F]-DPA-714
| Study group | Role | What they receive |
|---|---|---|
| ICVD | ischemic cerebrovascular diseases Receives: Radiation: Radiation: PET-MRI with [18F]-DPA-714 | |
| Neurological Autoimmune Diseases | Multiple Sclerosis，Neuromyelitis Optica Spectrum Disorders and Autoimmune Encephalitis Receives: Radiation: Radiation: PET-MRI with [18F]-DPA-714 | |
| other | other encephalomyelitis Receives: Radiation: Radiation: PET-MRI with [18F]-DPA-714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in TSPO Radiotracer Uptake
Quantify the regional neuroinflammatory load, measured as binding of PET tracer to TSPO.
Measured: 12 months
Secondary outcomes (7)
Free Diffusing Water Fraction
Calculated using MR-DWI
Measured: 12 months
Peripheral Levels of Pro-Inflammatory Cytokines
Evaluated using blood samples, including IL-6, IL-4, IL-10, hs-CRP and PCT etc,al
Measured: 12 months
CSF Levels of Pro-Inflammatory Cytokines
Evaluated using cerebrospinal fluid, IL-6, IL-4, IL-10, hs-CRP and PCT etc, al
Measured: 12 months
CSF Levels of neural injury markers
Evaluated using cerebrospinal fluid, GFAP, NFL and sTREM2 etc, al
Measured: 12 months
MRI Correlation
Correlation of white matter lesion volume and MRI measures of white matter tract injury determined from DTI with measures of TSPO uptake
Measured: 12 months
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 cerebrospinal fluid
Measured: 12 months
Neural injury markers correlation
Correlation of PET derived measures of TSPO uptake with neural injury markers ( GFAP, NFL and sTREM2) in the cerebrospinal fluid
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jul 2024
- Primary completionJun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jianmin Pharmaceutical Group Co., LTD.
- Responsible party
- Principal investigator, Wei Wang, Tongji Hospital
- Investigators
- Wei Wang, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467773
- Sponsor's protocol ID
- PETinCNS
- Status last verified
- Apr 2025
- First submitted
- 12 Jun 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31296369Kwon 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.
PubMed 33239064Voet 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.
PubMed 30578090Kreisl 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.
PubMed 33098803Zhang 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.
PubMed 38441089
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06467773
- Acronym / sponsor ID
- PETinCNS
- Conditions
- Central Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Jianmin Pharmaceutical Group Co., LTD.
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICVD | – | Radiation: Radiation: PET-MRI with [18F]-DPA-714ischemic cerebrovascular diseases |
| Neurological Autoimmune Diseases | – | Radiation: Radiation: PET-MRI with [18F]-DPA-714Multiple Sclerosis，Neuromyelitis Optica Spectrum Disorders and Autoimmune Encephalitis |
| other | – | Radiation: Radiation: PET-MRI with [18F]-DPA-714other encephalomyelitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (1 listed)
- -Clinical diagnosis of ischemic stroke, autoimmune ecephalitis, Neuromyelitis optica spectrum disorders, or multiple sclerosis, etc.al
Key exclusion criteria (6 listed)
- Claustrophobia
- Metal Implants
- Pregancy
- Breast-feeding
- Renal insufficiency (GFR < 60 mL/min/1.73m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation: PET-MRI with [18F]-DPA-714Radiation: PET-MRI with [18F]-DPA-714 | Radiation | ICVD, Neurological Autoimmune Diseases, other |
Primary outcome
Changes in TSPO Radiotracer Uptake
Time frame: 12 months
Quantify the regional neuroinflammatory load, measured as binding of PET tracer to TSPO.
7 secondary outcomes
Free Diffusing Water Fraction
Time frame: 12 months
Peripheral Levels of Pro-Inflammatory Cytokines
Time frame: 12 months
CSF Levels of Pro-Inflammatory Cytokines
Time frame: 12 months
CSF Levels of neural injury markers
Time frame: 12 months
MRI Correlation
Time frame: 12 months
Inflammatory Markers correlation
Time frame: 12 months
Neural injury markers correlation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Results publication: PubMed 31296369Shi 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.
- Results publication: PubMed 33239064Kwon 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.
- Results publication: PubMed 30578090Voet 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.
- Results publication: PubMed 33098803Kreisl 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.
- Results publication: PubMed 38441089Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Wang, MD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Diseases, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luo-qi Zhou, MD (86-27-83663337, zhouluoqi@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in TSPO Radiotracer Uptake (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06467773, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.