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

Parkinson Disease Clinical Trial

Official title:

The Novel 18F-labeled MAO-B PET/CT Imaging on Parkinsonism Patients of Chinese Population: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010290
• Other study ID #: MAO-B PET/CT STUDY
• Status: Recruiting
• Start date: November 30, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Anhui Provincial Hospital
• Contact: Qiang Xie, MD
• Phone: +8613721108043
• Email: xieqiang1980[@]ustc.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of China University of Science and Technology	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinical parameters	Clinical parameters include sex, age, Hoehn-Yahr Stage, and Unified Parkinson's disease rating scale (UPDRS).	60 days
Secondary	Correlation coefficient 1	Correlation analysis of SUVR between 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions.	60 days
Secondary	Correlation coefficient 2	Correlation analysis between SUVR of 18F-SMBT-1 PET/CT in the key cerebral regions and clinical parameters.	60 days