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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: 18F-SMBT-1

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Qiang Xie, MD; Phone Number: +8613721108043; Email: xieqiang1980@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • The First Affiliated Hospital of China University of Science and Technology
      • Contact: Qiang Xie, MD; Phone Number: +8613721108043; Email: xieqiang1980@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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-FDG; 18F-FP-CIT
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-FDG; 18F-FP-CIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	60 days
Clinical parameters	Clinical parameters include sex, age, Hoehn-Yahr Stage, and Unified Parkinson's disease rating scale (UPDRS).	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation coefficient 1	Correlation analysis of SUVR between 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions.	60 days
Correlation coefficient 2	Correlation analysis between SUVR of 18F-SMBT-1 PET/CT in the key cerebral regions and clinical parameters.	60 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: PET/CT
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: MAO-B PET/CT STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No