Clinical trial NCT02495649: Evaluation of Myocardial Sympathetic Denervation in Parkinson's Disease Using [18F]FDOPA
Official title: Evaluation of Myocardial Sympathetic Denervation in Parkinson's Disease Using [18F]FDOPA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
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:

1. Age \< 18
2. Previous diagnosed Heart Disease.
3. History of High blood pressure.
4. On medications that influence the sympathetic system.

Primary outcomes:
measure: The uptake of [18F]FDOPA will be measured by the ratio between the uptake in the heart and the uptake in the liver.
timeFrame: paitents will be scanned in PET- CT scaner for 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Einat Even Sapir, Phd, MD
role: PRINCIPAL_INVESTIGATOR
References: