Parkinson DiseaseNCT06010290
The Novel 18F-labeled MAO-B PET Tracer Study in Parkinsonism Patients
An observational study of Parkinson Disease, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This study mainly aims to prospectively evaluate the changes of reactive astrogliosis in Parkinsonism patients of Chinese population by the novel 18F-labeled MAO-B PET tracer. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 18F-SMBT-1
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2022to 31 Dec 2023
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population are recruited from the Department of Neurology of the First Affiliated Hospital of University of Science and Technology of China (USTC).
Who may be able to join
- Aged from 40 to 90 years old.
- Clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical Parkinsonism syndromes.
- Can cooperate with 18F-FDG PET/CT, 18F-FP-CIT PET/CT and 3D T1-weighted structural MR scans.
- Complete clinical data, including modified Hoehn and Yahr staging scale and the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Who cannot join
- Cannot cooperate with PET/CT or MR examination.
- Associated with brain diseases such as stroke, brain trauma, brain tumor, and cranial surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China University of Science and Technology
Hefei, Anhui, 230000
Qiang Xie, MD, +8613721108043, xieqiang1980@ustc.edu.cn
About this study
Official title: The Novel 18F-labeled MAO-B PET/CT Imaging on Parkinsonism Patients of Chinese Population: a Prospective Study
This study mainly aims to prospectively evaluate the changes of reactive astrogliosis in Parkinsonism patients of Chinese population by the novel 18F-labeled MAO-B PET tracer.
Read the detailed description
18F-SMBT-1, the novel 18F-labeled MAO-B PET tracer, was evaluated reactive astrogliosis in Alzheimer's disease successfully. In this prospective study, we assess the changes of reactive astrocytes in cerebral gray matter and white matter on Parkinson's disease by 18F-SMBT-1 PET/CT imaging among Chinese population.
- Conditions
- Parkinson Disease
- Being tested
- 18F-SMBT-1
- Keywords
- PET/CT
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-SMBT-1Drug
Also called 18F-FP-CIT, 18F-FDG
Each participant receives intravenous injection of 18F-SMBT-1, and undergo PET/CT imaging within the special time. 18F-FP-CIT and 18F-FDG PET/CT are used to assess the change of cerebral dopamine transporters and glucose metabolism for auxiliary diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Parkinsonism patients | This group/cohort comprises clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical Parkinsonism syndromes, and each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection. Receives: Drug: 18F-SMBT-1 | |
| Health control | Each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection. Receives: Drug: 18F-SMBT-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard uptake value ratio (SUVR)
Standard uptake value ratio of 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions using the cerebellar cortex or subcortical white matter as a reference region
Measured: 60 days
Clinical parameters
Clinical parameters include sex, age, Hoehn-Yahr Stage, and Unified Parkinson's disease rating scale (UPDRS).
Measured: 60 days
Secondary outcomes (2)
Correlation coefficient 1
Correlation analysis of SUVR between 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions.
Measured: 60 days
Correlation coefficient 2
Correlation analysis between SUVR of 18F-SMBT-1 PET/CT in the key cerebral regions and clinical parameters.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start30 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qiang Xie, MD, Study chair, The First Affiliated Hospital of China University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010290
- Sponsor's protocol ID
- MAO-B PET/CT STUDY
- Status last verified
- Nov 2022
- First submitted
- 10 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Novel 18F-labeled MAO-B PET/CT Imaging on Parkinsonism Patients of Chinese Population: a Prospective Study
- ClinicalTrials.gov ID
- NCT06010290
- Acronym / sponsor ID
- MAO-B PET/CT STUDY
- Conditions
- Parkinson Disease
- Keywords
- PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Aug 2023 (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 study mainly aims to prospectively evaluate the changes of reactive astrogliosis in Parkinsonism patients of Chinese population by the novel 18F-labeled MAO-B PET tracer.
Detailed description
18F-SMBT-1, the novel 18F-labeled MAO-B PET tracer, was evaluated reactive astrogliosis in Alzheimer's disease successfully. In this prospective study, we assess the changes of reactive astrocytes in cerebral gray matter and white matter on Parkinson's disease by 18F-SMBT-1 PET/CT imaging among Chinese population.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinsonism patients | – | Drug: 18F-SMBT-1This group/cohort comprises clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical Parkinsonism syndromes, and each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection. |
| Health control | – | Drug: 18F-SMBT-1Each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are recruited from the Department of Neurology of the First Affiliated Hospital of University of Science and Technology of China (USTC).
Key inclusion criteria (4 listed)
- Aged from 40 to 90 years old.
- Clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical Parkinsonism syndromes.
- Can cooperate with 18F-FDG PET/CT, 18F-FP-CIT PET/CT and 3D T1-weighted structural MR scans.
- Complete clinical data, including modified Hoehn and Yahr staging scale and the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Key exclusion criteria (2 listed)
- Cannot cooperate with PET/CT or MR examination.
- Associated with brain diseases such as stroke, brain trauma, brain tumor, and cranial surgery.
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-SMBT-1Also: 18F-FP-CIT, 18F-FDGEach participant receives intravenous injection of 18F-SMBT-1, and undergo PET/CT imaging within the special time. 18F-FP-CIT and 18F-FDG PET/CT are used to assess the change of cerebral dopamine transporters and glucose metabolism for auxiliary diagnosis. | Drug | Health control, Parkinsonism patients |
Primary outcome
Standard uptake value ratio (SUVR)
Time frame: 60 days
Standard uptake value ratio of 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions using the cerebellar cortex or subcortical white matter as a reference region
Clinical parameters
Time frame: 60 days
Clinical parameters include sex, age, Hoehn-Yahr Stage, and Unified Parkinson's disease rating scale (UPDRS).
2 secondary outcomes
Correlation coefficient 1
Time frame: 60 days
Correlation coefficient 2
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- 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. This study is not recruiting at the moment.
Qiang Xie, MD study chair
The First Affiliated Hospital of China University of Science and Technology
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 Parkinson Disease, run by Anhui Provincial 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 4 inclusion and 2 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 24 Aug 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. 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?
Contact Qiang Xie, MD (+8613721108043, xieqiang1980@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake value ratio (SUVR) (time frame: 60 days). The study lists 2 primary outcomes in all. 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 24 Aug 2023.