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

January 13, 2020 updated by: michal roll, Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Recruiting
        • Sourasky Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: [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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The uptake of [18F]FDOPA will be measured by the ratio between the uptake in the heart and the uptake in the liver.
Time Frame: paitents will be scanned in PET- CT scaner for 10 minutes

The uptake value of [18F]FDOPA will be measured by the ratio of standard uptake value (SUV) in the heart and the SUV in the liver.

Normal uptake will be calculated by the mean uptake ratio in the healthy population (plus minus standard deviation) and used to compare to patients with abnormal [18F]FDOPA scan of the basal ganglia.
paitents will be scanned in PET- CT scaner for 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Einat Even Sapir, PhD, MD, Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 13, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMO-15-ES-0606-14-TLV-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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