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

NCT06010290 | Unknown

• 1 other identifier: MAO-B PET/CT STUDY
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

PET/CT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Correlation coefficient 1

  60 days

• Correlation coefficient 2

  60 days

Study Arms (2)

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

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

Interventions

18F-SMBT-1 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.

Also known as: 18F-FP-CIT, 18F-FDG

Health control; Parkinsonism patients

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• Cannot cooperate with PET/CT or MR examination.
• Associated with brain diseases such as stroke, brain trauma, brain tumor, and cranial surgery.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

The First Affiliated Hospital of China University of Science and Technology

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Qiang Xie, MD

  The First Affiliated Hospital of China University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Qiang Xie, MD

CONTACT

+8613721108043; xieqiang1980@ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 24, 2023
• Study Start: November 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 24, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)