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

NCT ID: NCT02495649

Last Updated: 2020-01-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Parkinson

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type OTHER

[18F]-DOPA

Intervention Type OTHER

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

Intervention Type DEVICE

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

Intervention Type OTHER

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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michal roll

Michal Roll PhD,MBA, DIRECTOR R&D devition

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Adi Feiner, B.sc

Role: CONTACT

03-6974373

Facility Contacts

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ira korovin

Role: primary

036974373

Other Identifiers

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TASMO-15-ES-0606-14-TLV-CTIL

Identifier Type: -

Identifier Source: org_study_id

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