Hepatitis CNCT03973502
Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PD
A study testing 18F-DOPA PET in people with Hepatitis C and Hepatitis B, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hepatitis B, Parkinson Disease
- What is being tested?
- 18F-DOPA PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jun 2017to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Univeristy Hospital
Taipei, 100
Yen Ruoh Fang, MD, PhD, 886-2-23123456 ext. 65581, rfyen@ntu.edu.tw
About this study
Official title: Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) in Research of the Association Between HCV Infection and Parkinson's Disease.
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.
Read the 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.
- Conditions
- Hepatitis C, Hepatitis B, Parkinson Disease
- Being tested
- 18F-DOPA PET
- Keywords
- Hepatitis C, Hepatitis B, Parkinson's disease, 18F-FDOPA PET, MRS, MRS
- Medical subject headings
- Hepatitis C, Hepatitis B, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DOPA PETDrug
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 group | Role | What they receive |
|---|---|---|
| 18F-DOPA PET | Experimental | PET/CT Receives: Drug: 18F-DOPA PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: in 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start12 Jun 2017
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973502
- Sponsor's protocol ID
- 201506041MINA
- Status last verified
- May 2022
- First submitted
- 30 May 2019
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) in Research of the Association Between HCV Infection and Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT03973502
- Acronym / sponsor ID
- 201506041MINA
- Conditions
- Hepatitis C, Hepatitis B, Parkinson Disease
- Keywords
- Hepatitis C, Hepatitis B, Parkinson's disease, 18F-FDOPA PET, MRS, MRS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-DOPA PET | Experimental | Drug: 18F-DOPA PETPET/CT |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Test Group
- Control Group
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-DOPA PETOne 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. | Drug | 18F-DOPA PET |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-DOPA PET in people with Hepatitis C and Hepatitis B, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET imaging (time frame: in 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.