NCT04618679

Brief Summary

-\[18F\]Fluoro-L-3,4-dihydroxyphenylalanine (18F-FDOPA) positron emission tomography (PET) is a imaging marker for presynaptic dopaminergic neuronal function. The decreased uptake of 18F-FDOPA in the posterior putamen is demonstrated in the early course of PD, and could differentiate early PD from healthy controls. The objective of this study is to investigate the evidence of presynaptic dopaminergic neuronal dysfunction in the preclinical stage of PD, which may be associated with HCV infection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 6, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

November 1, 2020

Last Update Submit

November 1, 2020

Conditions

Hepatitis C

Keywords

HBV,Parkinson's disease,18F-FDOPA PET

Outcome Measures

Primary Outcomes (1)

  • Application of 18F-FDOPA PET in research of the association between HCV infection and Parkinson's disease.

    To evaluate the uptake of 18F-FDOPA in the basal ganglia of patients with HCV infection. Use 18F-FDOPA PET as an imaging marker to diagnosis preclincal Parkinson's disease in patients with HCV infection.

    2 weeks

Secondary Outcomes (1)

  • Application of 18F-FDOPA PET in research of the association between HCV infection and Parkinson's disease.

    2 weeks

Study Arms (1)

18F-FDOPA PET

Patients with HCV infection receive 18F-FDOPA PET to investigate preclinical Parkinson's disease.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient department of hospital

Adults (older than 20-year-old) with HCV infection and agree to accept 18F-FDOPA PET examination.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Douliu, Yunlin County, 640, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Chia-Ju v Liu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Ju Liu, MD

CONTACT

886972655524Y05955@ms1.ylh.gov.tw

Kai-Chieh Chang, MD

CONTACT

886972652523b94401022@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2020

First Posted

November 6, 2020

Study Start

November 2, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

November 6, 2020

Record last verified: 2020-10

Locations

TW(1)