Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| OTHER | [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 |
| DEVICE | 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 |
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.