CClinicalTrials.gg
Status unknownNCT06010290Updated Aug 24, 2023

The Novel 18F-labeled MAO-B PET Tracer Study in Parkinsonism Patients

An observational study in Parkinson Disease, sponsored by Anhui Provincial Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by Anhui Provincial Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
40 Years to 90 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Parkinson Disease

Keywords

  • PET/CT
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In context

Parkinson Disease

4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's planned enrollment of 80 is below the median of 96 across 1,056 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Anhui Provincial Hospital is the lead sponsor of 129 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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).

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • Cannot cooperate with PET/CT or MR examination.
  • Associated with brain diseases such as stroke, brain trauma, brain tumor, and cranial surgery.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Drug: 18F-SMBT-1

Interventions

  • Drug18F-SMBT-1

    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.

    Also known as: 18F-FP-CIT, 18F-FDG

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 60 days

  2. Clinical parameters

    Clinical parameters include sex, age, Hoehn-Yahr Stage, and Unified Parkinson's disease rating scale (UPDRS).

    Time frame: 60 days

Secondary outcomes

  1. Correlation coefficient 1

    Correlation analysis of SUVR between 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions.

    Time frame: 60 days

  2. Correlation coefficient 2

    Correlation analysis between SUVR of 18F-SMBT-1 PET/CT in the key cerebral regions and clinical parameters.

    Time frame: 60 days

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Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of China University of Science and Technology
    Hefei, Anhui 230000, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06010290
Lead sponsor
Anhui Provincial Hospital
Responsible party
Sponsor
First posted
Aug 24, 2023
Start date
Nov 30, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Aug 24, 2023

Study contacts

Qiang Xie, MD
Contact
xieqiang1980@ustc.edu.cn
+8613721108043
Qiang Xie, MD
study chair · The First Affiliated Hospital of China University of Science and Technology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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