Autoimmune EncephalomyelitisNCT05293405
Neuroinflammatory PET Imaging in Autoimmune Encephalomyelitis
A study testing 18F-DPA-714 PET in people with Autoimmune Encephalomyelitis, run by Ruijin Hospital at 1 site in China.
Trial summary
Autoimmune encephalomyelitis is a heterogeneous group of central nervous system (CNS) autoimmune diseases characterized by the production of anti-neuron-associated autoantibodies which target neuronal surface proteins, synaptic receptors and intracellular antigens. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Encephalomyelitis
- What is being tested?
- 18F-DPA-714 PET
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with onset for less than 2 years
- Serum autoantibody positive
- cognitive impairment or movement disorder diagnosed by two or more certified specialists.
- able to understand the purpose of clinical research and test plan
- In the brain and spine cord MR assessment, it is judged as "normal"
Who cannot join
- Patients who do not meet the clinical、laboratory and imaging criteria of immune-related cognitive and movement disorders
- Medical history of surgery, trauma, stroke, tumor in brain or spine cord
- Alcoholism or drug dependence (addiction)
- Patients with pregnancy
- Healthy Volunteers group:
- Any major mental illness; history of schizophrenia or schizoaffective disorder
Show all 10Show fewer
- Any important neurological disease, such as cerebrovascular disease, inflammation or infectious disease, demyelinating disease, neurodegenerative disease, trauma in brain or spine cord
- History of alcohol or drug abuse/dependence
- Medical history of cardiac and lung disease, tumors, blood disease, poorly controlled chronic diseases
- Patients with pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, 200025
Min Zhang, Dr., 0086-21-64370045, zm11518@rjh.com.cn
About this study
Official title: Neuroinflammatory Imaging Using TSPO PET Tracer in Paients With Autoimmune Encephalomyelitis
Autoimmune encephalomyelitis is a heterogeneous group of central nervous system (CNS) autoimmune diseases characterized by the production of anti-neuron-associated autoantibodies which target neuronal surface proteins, synaptic receptors and intracellular antigens. MRI, as a current first-line imaging tool of CNS inflammation, is difficult to diagnose them because the majority of patients have normal MRI images, and only a few may show local signal or structural abnormalities (including inflammation, edema, or atrophy). The 18 kDa translocator protein (TSPO) expression in the CNS is upregulated in response to microglia activation. DPA-714 is high affinity for binding to TSPO, making 18F-labeled DPA-714 (18F-DPA-714) PET a very promising diagnostic imaging tool for neuroinflammation in patients with autoimmune encephalomyelitis.This study aims to explore the value of 18F-DPA-714 PET in the early diagnosis, therapeutic assessment and prognosis in patients with autoimmune encephalomyelitis.
- Conditions
- Autoimmune Encephalomyelitis
- Being tested
- 18F-DPA-714 PET
- Medical subject headings
- Encephalomyelitis, Autoimmune, Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DPA-714 PETDiagnostic test
TSPO expression are quantitatively analyzed in all brain regions or spinal cord using 18F-DPA-714 PET
| Study group | Role | What they receive |
|---|---|---|
| Patients Group | Experimental | Not described Receives: Diagnostic Test: 18F-DPA-714 PET |
| Healthy Volunteers Group | Sham comparator | Not described Receives: Diagnostic Test: 18F-DPA-714 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSPO expression level
quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord
Measured: Baseline
TSPO expression level
quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord
Measured: 3 months after baseline
TSPO expression level
quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start14 Dec 2021
- Primary completion13 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune EncephalomyelitisStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293405
- Sponsor's protocol ID
- (2021)CER(375)
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meng H, He L, Chunyu H, Zhou Q, Wang J, Qu Q, Hai W, Zhang Y, Li B, Zhang M, Chen S. 18F-DPA714 PET/MRI as a potential imaging tool for detecting possible antibody-negative autoimmune encephalitis: a prospective study. J Neurol. 2024 Dec;271(12):7592-7604. doi: 10.1007/s00415-024-12690-w. Epub 2024 Sep 19.
PubMed 39294471
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammatory Imaging Using TSPO PET Tracer in Paients With Autoimmune Encephalomyelitis
- ClinicalTrials.gov ID
- NCT05293405
- Acronym / sponsor ID
- (2021)CER(375)
- Conditions
- Autoimmune Encephalomyelitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 13 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Mar 2022 (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.
Autoimmune encephalomyelitis is a heterogeneous group of central nervous system (CNS) autoimmune diseases characterized by the production of anti-neuron-associated autoantibodies which target neuronal surface proteins, synaptic receptors and intracellular antigens. MRI, as a current first-line imaging tool of CNS inflammation, is difficult to diagnose them because the majority of patients have normal MRI images, and only a few may show local signal or structural abnormalities (including inflammation, edema, or atrophy). The 18 kDa translocator protein (TSPO) expression in the CNS is upregulated in response to microglia activation. DPA-714 is high affinity for binding to TSPO, making 18F-labeled DPA-714 (18F-DPA-714) PET a very promising diagnostic imaging tool for neuroinflammation in patients with autoimmune encephalomyelitis.This study aims to explore the value of 18F-DPA-714 PET in the early diagnosis, therapeutic assessment and prognosis in patients with autoimmune encephalomyelitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Group | Experimental | Diagnostic Test: 18F-DPA-714 PET |
| Healthy Volunteers Group | Sham comparator | Diagnostic Test: 18F-DPA-714 PET |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with onset for less than 2 years
- Serum autoantibody positive
- cognitive impairment or movement disorder diagnosed by two or more certified specialists.
- able to understand the purpose of clinical research and test plan
- In the brain and spine cord MR assessment, it is judged as "normal"
Key exclusion criteria (10 listed)
- Patients who do not meet the clinical、laboratory and imaging criteria of immune-related cognitive and movement disorders
- Medical history of surgery, trauma, stroke, tumor in brain or spine cord
- Alcoholism or drug dependence (addiction)
- Patients with pregnancy
- Any major mental illness; history of schizophrenia or schizoaffective disorder
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 |
|---|---|---|
| 18F-DPA-714 PETTSPO expression are quantitatively analyzed in all brain regions or spinal cord using 18F-DPA-714 PET | Diagnostic test | Healthy Volunteers Group, Patients Group |
Primary outcome
TSPO expression level
Time frame: Baseline
quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord
TSPO expression level
Time frame: 3 months after baseline
quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord
TSPO expression level
Time frame: 12 months after baseline
quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39294471Meng H, He L, Chunyu H, Zhou Q, Wang J, Qu Q, Hai W, Zhang Y, Li B, Zhang M, Chen S. 18F-DPA714 PET/MRI as a potential imaging tool for detecting possible antibody-negative autoimmune encephalitis: a prospective study. J Neurol. 2024 Dec;271(12):7592-7604. doi: 10.1007/s00415-024-12690-w. Epub 2024 Sep 19.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-DPA-714 PET in people with Autoimmune Encephalomyelitis, run by Ruijin 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSPO expression level (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05293405, which also lists 1 linked publication.
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 18 Apr 2023.