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

Recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: 18F-SMBT-1

• Registration Number: NCT06010290
• Lead Sponsor: Anhui Provincial Hospital

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.

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 Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-30
• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinsonism patients	18F-SMBT-1	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.
Health control	18F-SMBT-1	Each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of China University of Science and Technology; 🇨🇳 Hefei, Anhui, China