NCT02495649

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

June 3, 2015

Last Update Submit

January 13, 2020

Conditions

Parkinson

Outcome Measures

Primary Outcomes (1)

  • 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.

    paitents will be scanned in PET- CT scaner for 10 minutes

Study Arms (1)

[18F]-DOPA

OTHER

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]-DOPADevice: PET-CT

Interventions

[18F]-DOPAOTHER

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

[18F]-DOPA
PET-CTDEVICE

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

[18F]-DOPA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Interventions

fluorodopa F 18Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Einat Even Sapir, Phd, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Feiner, B.sc

CONTACT

03-6974373advar@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michal Roll PhD,MBA, DIRECTOR R&D devition

Study Record Dates

First Submitted

June 3, 2015

First Posted

July 13, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2015

Study Completion

July 1, 2021

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

IL(1)