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UnknownNCT02495649

Evaluation of Myocardial Sympathetic Denervation in Parkinson's Disease Using [18F]FDOPA

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Tel-Aviv Sourasky Medical Center · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to evaluate the added value of PET-CT with \[18F\]FDOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease. 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.

Detailed description

L-3,4-dihydroxy-6-\[18F\]fluoro-phenylalanine (\[18F\]FDOPA) might be a useful tracer for assessing myocardial sympathetic denervation in Parkinson's disease (PD) Patients. Compared to the routinely used I123 MIBG scan, \[18F\]FDOPA seems to have an advantage for the following reasons: 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

Interventions

TypeNameDescription
OTHER[18F]-DOPATo evaluate the feasibility of PET-CT with \[18F\]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
DEVICEPET-CTTo evaluate the feasibility of PET-CT with \[18F\]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease

Timeline

Start date
2015-08-01
Primary completion
2015-09-01
Completion
2021-07-01
First posted
2015-07-13
Last updated
2020-01-18

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT02495649. Inclusion in this directory is not an endorsement.