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出境医 / 临床实验 / Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PD

Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PD

Study Description
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Hepatitis B Parkinson Disease Drug: 18F-DOPA PET Not Applicable

Detailed Description:

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: 18F-DOPA PET
PET/CT
 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.
Outcome Measures
Primary Outcome Measures :
  1. 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.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Taiwan
National Taiwan Univeristy Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yen Ruoh Fang, MD, PhD    886-2-23123456 ext 65581    rfyen@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date March 12, 2021
Actual Study Start Date  ICMJE June 12, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PD
Official Title  ICMJE Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) in Research of the Association Between HCV Infection and Parkinson's Disease.
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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hepatitis C
  • Hepatitis B
  • Parkinson Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 18F-DOPA PET
PET/CT
Intervention: Drug: 18F-DOPA PET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2019) 		230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973502
Other Study ID Numbers  ICMJE 201506041MINA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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