Evaluation of Myocardial Sympathetic Denervation in Parkinson's Disease Using [18F]FDOPA
NCT ID: NCT02495649
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-08-31
2021-07-31
Brief Summary
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The investigators expect to see normal values of uptake ratio of \[18F\]FDOPA , in patients with no synuclein underline pathology or previously known cardiovascular disease (no history of high blood pressure or take medications that influence the sympathetic system- exclusion criteria). Low values of uptake ratio is presumed to be found in patients diagnosed with Parkinson's disease or other synuclein pathology.
The expected normal ratio of Heart/liver uptake values will be determined from scans of patients refered to \[18F\]FDOPA scan and were found to have normal \[18F\]FDOPA scan of the basal ganglia and no cardiovascular diseases.
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Detailed Description
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1. meta-iodobenzylguanidine (MIBG) is a false analog of norepinephrine while \[18F\]FDOPA is the radiolabelled form of DOPA, a direct precursor of dopamine which is subsequently converted to norepinephrine
2. 123I MIBG, un-like norepinephrine, dose not undergo intracellular metabolism (19) while \[18F\]FDOPA undergo complex intracellular metabolism (17)
3. Studies have shown that I123 MIBG reuptake is almost exclusive by uptake mechanism 1. Uptake-2 mechanism of 123I-MIBG by the myocardium is not significant. Reuptake of norepinephrine (NE) in the synaptic cleft and is mainly by uptake 1 system but also in small amount by uptake 2 systems. The investigators assumption is that this double mechanism of reuptake will increase the concentration of \[18F\]FDOPA for better imaging
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[18F]-DOPA
evaluate the added value of PET-CT with \[18F\]-DOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease.
[18F]-DOPA
To evaluate the feasibility of PET-CT with \[18F\]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
PET-CT
To evaluate the feasibility of PET-CT with \[18F\]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
Interventions
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[18F]-DOPA
To evaluate the feasibility of PET-CT with \[18F\]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
PET-CT
To evaluate the feasibility of PET-CT with \[18F\]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
Eligibility Criteria
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Inclusion Criteria
2. Signed Informed Consent
3. Patients referred for F-dopa scan of basal ganglia in the evaluation of Parkinson's disease or other extra pyramidal motor disorders.
4. Patients diagnosed with Parkinson's disease.
Exclusion Criteria
2. Previous diagnosed Heart Disease.
3. History of High blood pressure.
4. On medications that influence the sympathetic system.
18 Years
ALL
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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michal roll
Michal Roll PhD,MBA, DIRECTOR R&D devition
Principal Investigators
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Einat Even Sapir, Phd, MD
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Locations
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Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TASMO-15-ES-0606-14-TLV-CTIL
Identifier Type: -
Identifier Source: org_study_id
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