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

Primary Purpose

Parkinson

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
[18F]-DOPA
PET-CT
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

[18F]-DOPA

Arm Description

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.

Outcomes

Primary Outcome Measures

The uptake of [18F]FDOPA will be measured by the ratio between the uptake in the heart and the uptake in the liver.
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.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2015
Last Updated
January 13, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02495649
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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 123I MIBG, un-like norepinephrine, dose not undergo intracellular metabolism (19) while [18F]FDOPA undergo complex intracellular metabolism (17) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]-DOPA
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
[18F]-DOPA
Intervention Description
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
Intervention Name(s)
PET-CT
Intervention Description
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
Primary Outcome Measure Information:
Title
The uptake of [18F]FDOPA will be measured by the ratio between the uptake in the heart and the uptake in the liver.
Description
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.
Time Frame
paitents will be scanned in PET- CT scaner for 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Signed Informed Consent Patients referred for F-dopa scan of basal ganglia in the evaluation of Parkinson's disease or other extra pyramidal motor disorders. Patients diagnosed with Parkinson's disease. Exclusion Criteria: Age < 18 Previous diagnosed Heart Disease. History of High blood pressure. On medications that influence the sympathetic system.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adi Feiner, B.sc
Phone
03-6974373
Email
advar@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Even Sapir, Phd, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ira korovin
Phone
036974373
Email
irako@tlvmc.gov.il

12. IPD Sharing Statement

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

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