Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PD
1 other identifier
interventional
230
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
June 12, 2017
CompletedFirst Submitted
Initial submission to the registry
May 30, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedMay 17, 2023
May 1, 2022
6 years
May 30, 2019
May 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PET imaging
Visual interpretation will be performed first by two independent readers to record if there is any abnormal 18F-FES accumulation. The presence, number, size, character, and location of suspected lesions will be filed for each patient in this study. The final results will be validated by tissue proof, correlation with other imaging, or follow-up results. Semi-quantitative analysis will be performed for each lesion suspected during visual interpretation. Standardized uptake values (SUV) will be obtained by placing regions of interest (ROIs) around the lesions that are identified on visual analysis. The maximum SUV (SUVmax) will be recorded. Volumetric parameters will be performed by placing volume of interests (VOIs) around the suspected lesions. VOIs will be generated using defined fix SUV thresholds or algorithm-generated isocontours. Manual adjustment of VOIs is allowed when non-tumoral tissue is incorrectly included by automatic method.
in 3 days
Study Arms (1)
18F-DOPA PET
EXPERIMENTALPET/CT
Interventions
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.
Eligibility Criteria
You may qualify if:
- Test Group
- Age：above 20 years old with HBV or HCV subjects.
- Patient agrees to participate in the study and receive UPDRS, MMSE, BDI II, MRI and PET imaging.
- Control Group
- 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.
- Patient agrees to participate in the study and receive UPDRS, MMSE, BDI II, MRI and PET imaging.
You may not qualify if:
- Patients could not receive PET and MRI studies, including panic mood to MRI study, allergy to contrast medium, hemodynamic instability.
- Patients with pregnancy or recently having a plan for pregnancy.
- Patient or family who does not agree to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan Univeristy Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2019
First Posted
June 4, 2019
Study Start
June 12, 2017
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
May 17, 2023
Record last verified: 2022-05