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

Sponsor
Anhui Provincial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06010290
Collaborator
(none)
80
Enrollment
1
Location
13
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

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

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
The Novel 18F-labeled MAO-B PET/CT Imaging on Parkinsonism Patients of Chinese Population: a Prospective Study
Actual Study Start Date :
Nov 30, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.
Other Names:
  • 18F-FP-CIT
  • 18F-FDG

    		•
    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
    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.
    Other Names:
  • 18F-FP-CIT
  • 18F-FDG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Standard uptake value ratio (SUVR) [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

    2. Clinical parameters [60 days]

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

    Secondary Outcome Measures

    1. Correlation coefficient 1 [60 days]

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

    2. Correlation coefficient 2 [60 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    • Cannot cooperate with PET/CT or MR examination.

    • Associated with brain diseases such as stroke, brain trauma, brain tumor, and cranial surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of China University of Science and Technology Hefei Anhui China 230000

    Sponsors and Collaborators

    • Anhui Provincial Hospital

    Investigators

    • Study Chair: Qiang Xie, MD, The First Affiliated Hospital of China University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anhui Provincial Hospital
    ClinicalTrials.gov Identifier:
    NCT06010290
    Other Study ID Numbers:
    • MAO-B PET/CT STUDY
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Anhui Provincial Hospital
    PET/CT
    Additional relevant MeSH terms:
    Parkinson Disease
    Parkinsonian Disorders
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of Aug 24, 2023