Brain DiseaseNCT06851143
18F-DPA-714 PET/MR in Dysfunctional Brain Diseases
A study testing 18F-DPA-714 PET/MR scan in people with Brain Disease, run by Xijing Hospital.
Trial summary
This is a diagnostic pilot study that recruited 25 normal volunteers and 40 patients with dysfunctional brain diseases and performed 18F-DPA-714 PET/MR imaging to evaluate the correlation between the multimodal imaging features of dysfunctional brain diseases, to explore the potential pathological mechanisms of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Disease
- What is being tested?
- 18F-DPA-714 PET/MR scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dysfunctional disorders diagnosed according to the guidelines include: cognitive disorders, movement disorders, disorders of consciousness-like disorders, and autoimmune encephalitis. Signing the PET/MR informed consent form to volunteer for this study
Who cannot join
- Minors, pregnant women, nursing mothers, those with severe liver or kidney insufficiency, history of allergy to contrast media or other drugs. Diagnosis of viral encephalitis, acute myelitis, idiopathic epilepsy, antibody-negative AIE; diagnosis of any major disease; history of alcohol or drug abuse/dependence; history of cardiorespiratory disease, oncology, haematological disorders, poorly controlled chronic diseases; contraindications to PET/MR examination. History of head trauma, history of surgery. History of other neurological disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a diagnostic pilot study that recruited 25 normal volunteers and 40 patients with dysfunctional brain diseases and performed 18F-DPA-714 PET/MR imaging to evaluate the correlation between the multimodal imaging features of dysfunctional brain diseases, to explore the potential pathological mechanisms of neuroimmune activation, and to further analyse the value of PET/MR-based multimodal imaging in the diagnosis and differential diagnosis of dysfunctional brain diseases. and further analyse the diagnostic and differential diagnostic value of PET/MR-based multimodal imaging in dysfunctional brain diseases.
- Conditions
- Brain Disease
- Being tested
- 18F-DPA-714 PET/MR scan
- Keywords
- 18F-DPA-714 PET/MR, cognitive impairment, dyskinesia, Disorders of consciousness, Autoimmune encephalitis
- Medical subject headings
- Brain Diseases, Cognitive Dysfunction, Dyskinesias, Consciousness Disorders, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DPA-714 PET/MR scanDiagnostic test
Saline intravenous solution of 18F-DPA-714 administered at 0.1 mCi/kg by bodyweight
| Study group | Role | What they receive |
|---|---|---|
| Comparative study of different groups | Other | This study is planned to include approximately 25 normal volunteers and 40 patients with dysfunctional brain diseases. The screened subjects will undergo multimodal imaging data acquisition using integrated PET/MR (GE Signa). The SUV ratio (SUVR) of each brain region will be obtained using the cerebellum as a reference, and differences in [18F]DPA-714 uptake between patients and normal controls will be compared using voxel-based imaging analysis. PCA-based analysis of the distribution pattern of TSPO radioabnormalities in different types of patients. Pearson correlation-based analysis of the correlation between neuroimmune activation and structural and functional parameters. Receives: Diagnostic Test: 18F-DPA-714 PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Standardized uptake value (SUVmax)
Measured: 1 day from injection of the tracer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851143
- Sponsor's protocol ID
- KY20252023
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-DPA-714 PET/MR in Dysfunctional Brain Diseases
- ClinicalTrials.gov ID
- NCT06851143
- Acronym / sponsor ID
- KY20252023
- Conditions
- Brain Disease
- Keywords
- 18F-DPA-714 PET/MR, cognitive impairment, dyskinesia, Disorders of consciousness, Autoimmune encephalitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
This is a diagnostic pilot study that recruited 25 normal volunteers and 40 patients with dysfunctional brain diseases and performed 18F-DPA-714 PET/MR imaging to evaluate the correlation between the multimodal imaging features of dysfunctional brain diseases, to explore the potential pathological mechanisms of neuroimmune activation, and to further analyse the value of PET/MR-based multimodal imaging in the diagnosis and differential diagnosis of dysfunctional brain diseases. and further analyse the diagnostic and differential diagnostic value of PET/MR-based multimodal imaging in dysfunctional brain diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparative study of different groups | Other | Diagnostic Test: 18F-DPA-714 PET/MR scanThis study is planned to include approximately 25 normal volunteers and 40 patients with dysfunctional brain diseases. The screened subjects will undergo multimodal imaging data acquisition using integrated PET/MR (GE Signa). The SUV ratio (SUVR) of each brain region will be obtained using the cerebellum as a reference, and differences in [18F]DPA-714 uptake between patients and normal controls will be compared using voxel-based imaging analysis. PCA-based analysis of the distribution pattern of TSPO radioabnormalities in different types of patients. Pearson correlation-based analysis of the correlation between neuroimmune activation and structural and functional parameters. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dysfunctional disorders diagnosed according to the guidelines include: cognitive disorders, movement disorders, disorders of consciousness-like disorders, and autoimmune encephalitis. Signing the PET/MR informed consent form to volunteer for this study
Key exclusion criteria (1 listed)
- Minors, pregnant women, nursing mothers, those with severe liver or kidney insufficiency, history of allergy to contrast media or other drugs. Diagnosis of viral encephalitis, acute myelitis, idiopathic epilepsy, antibody-negative AIE; diagnosis of any major disease; history of alcohol or drug abuse/dependence; history of cardiorespiratory disease, oncology, haematological disorders, poorly controlled chronic diseases; contraindications to PET/MR examination. History of head trauma, history of surgery. History of other neurological disorders.
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 PET/MR scanSaline intravenous solution of 18F-DPA-714 administered at 0.1 mCi/kg by bodyweight | Diagnostic test | Comparative study of different groups |
Primary outcome
Maximum Standardized uptake value (SUVmax)
Time frame: 1 day from injection of the tracer
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 28 Feb 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-DPA-714 PET/MR scan in people with Brain Disease, run by Xijing Hospital.
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 1 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: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ying Guo Ying Guo (0086+15991459177, guoying01192022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Standardized uptake value (SUVmax) (time frame: 1 day from injection of the tracer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.