Clinical trial

Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) in Research of the Association Between HCV Infection and Parkinson's Disease.

Name

201506041MINA

Description

The objective of this study is to investigate the evidence of dopaminergic toxicity causing by HCV infection using 18F-FDOPA PET and MRS as imaging biomarkers.

Trial arms

Trial start

2017-06-12

Estimated PCD

2023-05-31

Trial end

2023-05-31

Treatment

18F-DOPA PET

One hour later all patient will be injected intravenously with 185 MBq (5mCi) 18F-FDOPA. PET emission data acquisition in 3-dimensional mode will be started at 60 minutes after tracer injection for 30 minutes.

Arms:

18F-DOPA PET

Size

230

Primary endpoint

PET imaging

in 3 days

Eligibility criteria

Inclusion Criteria: * Test Group 1. Age：above 20 years old with HBV or HCV subjects. 2. Patient agrees to participate in the study and receive UPDRS, MMSE, BDI II, MRI and PET imaging. * Control Group 1. Age：above 20 years old without carriers of Hepatitis B and C (ex. fatty liver), and no known neurological (ex. stroke, Parkinson's disease and degenerative neuropathy, etc.) and mental illness. 2. Patient agrees to participate in the study and receive UPDRS, MMSE, BDI II, MRI and PET imaging. Exclusion Criteria: 1. Patients could not receive PET and MRI studies, including panic mood to MRI study, allergy to contrast medium, hemodynamic instability. 2. Patients with pregnancy or recently having a plan for pregnancy. 3. Patient or family who does not agree to participate in the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 230, 'type': 'ESTIMATED'}}

Updated at

2023-05-17

1 organization

1 product

3 indications

Organization

National Taiwan University Hospital

Product

Indication

Indication

Indication