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

NCT ID: NCT06010290

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2023-12-31

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

18F-SMBT-1

Intervention Type: DRUG

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.

Health control

Each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection.

18F-SMBT-1

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

18F-FP-CIT; 18F-FDG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Xie, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of China University of Science and Technology

Locations

The First Affiliated Hospital of China University of Science and Technology

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Xie, MD

Role: CONTACT

xieqiang1980@ustc.edu.cn

+8613721108043

Facility Contacts

Qiang Xie, MD

Role: primary

xieqiang1980@ustc.edu.cn

+8613721108043

Other Identifiers

MAO-B PET/CT STUDY

Identifier Type: -

Identifier Source: org_study_id