Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PD
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|ClinicalTrials.gov Identifier: NCT03973502|
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Hepatitis B Parkinson Disease||Drug: 18F-DOPA PET||Not Applicable|
Parkinson's disease (PD) is the most common neurodegenerative disorder after Alzheimer's disease. It is characterized by degeneration of the dopaminergic neurons in substantia nigra and striatum, even before the clinical symptoms develop. Although the pathogenesis is still unclear, some viruses have been shown to be associated with acute or chronic parkinsonism. Recent studies have found that Hepatitis C virus (HCV) can replicate in the central nervous system, suggesting a possible link between PD and HCV. At the population and epidemiology level, the HCV infection and PD are strongly associated. At the molecular level, both HCV and PD have in common the overexpression of inflammatory biomarkers. Neuronal toxicity induced by HCV was also demonstrated. The positive association between HCV infection and PD has clinical implications for high endemic HCV areas, including Taiwan.
18F-FDOPA, an analog to L-DOPA, has been used as a positron-emitting compound for PET examination of patients affected by PD. It has been shown that putamen 18F-FDOPA uptakes are reduced by at least 35% at onset of symptoms, making the 18F-FDOPA PET as an imaging biomarker for detecting subclinical and preclinical parkinsonism. Earlier imaging study using magnetic resonance spectroscopy (MRS) to investigate cerebral effect of HCV also showed that chronic HCV infection had elevated choline/creatine ratios, a biomarker indicating inflammatory and infective conditions, in the basal ganglia and white matter.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) in Research of the Association Between HCV Infection and Parkinson's Disease.|
|Actual Study Start Date :||June 12, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: 18F-DOPA PET
Drug: 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.
- PET imaging [ Time Frame: in 3 days ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973502
|National Taiwan Univeristy Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Yen Ruoh Fang, MD, PhD 886-2-23123456 ext 65581 firstname.lastname@example.org|