Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients

NCT ID: NCT00468078

Last Updated: 2016-01-13

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to determine whether F-18 FPCIT is effective and safe radiopharmaceutical for the objective diagnosis of Parkinson's disease.

Detailed Description

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Parkinson's disease is a common neurodegenerative disorder with loss of dopaminergic terminals in the striatum. Essential tremor is one of the conditions most commonly misdiagnosed as parkinsonism, and early clinical differentiation between these conditions can be difficult. F-18 FPCIT is a promising radiopharmaceutical for PET imaging to assess the dopamine transporter in the striatum.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Parkinson's disease

Group Type EXPERIMENTAL

PET/CT

Intervention Type PROCEDURE

10min acquisition, 90min after injection of F-18 FPCIT

F-18 FPCIT

Intervention Type DRUG

5mCi, intravenous injection

B

ET+Normal

Group Type ACTIVE_COMPARATOR

PET/CT

Intervention Type PROCEDURE

10min acquisition, 90min after injection of F-18 FPCIT

F-18 FPCIT

Intervention Type DRUG

5mCi, intravenous injection

Interventions

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PET/CT

10min acquisition, 90min after injection of F-18 FPCIT

Intervention Type PROCEDURE

F-18 FPCIT

5mCi, intravenous injection

Intervention Type DRUG

Other Intervention Names

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Positron Emission Tomography

Eligibility Criteria

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Inclusion Criteria

Parkinson's disease

* Male or female with age over 40 years
* Clinical diagnosis of Parkinson's disease
* Ability to give informed consent

Essential tremor

* Male or female with age over 40 years
* Clinical diagnosis of Essential tremor
* Ability to give informed consent

Healthy volunteers

* Male or female with age over 40 years
* No any symptoms or sign suggesting Parkinson's disease or essential tremor
* Ability to give informed consent

Exclusion Criteria

Parkinson's disease and essential tremor

* Current pregnancy and breast feeding
* Current or past medical history of cardiac and neuropsychiatric disease
* Clinical evidence of dementia
* Inability to hold antiparkinsonian medication
* History of surgical therapy for tremor
* Severe or unstable medical or psychiatric condition
* Medication affecting CNS in last 6 months(e.g. CNS stimulants, sympathomimetics)
* Prior participation in other research protocol within 30 days

Healthy volunteers

* Current pregnancy and breast feeding
* Current or past medical history of cardiac and neuropsychiatric disease
* Severe or unstable medical or psychiatric condition
* Drug abuse or medication affecting CNS (e.g. CNS stimulants, sympathomimetics) within 6 months
* Prior participation in other research protocol within 30 days
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jae Seung Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Seung Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kazumata K, Dhawan V, Chaly T, Antonini A, Margouleff C, Belakhlef A, Neumeyer J, Eidelberg D. Dopamine transporter imaging with fluorine-18-FPCIT and PET. J Nucl Med. 1998 Sep;39(9):1521-30.

Reference Type BACKGROUND
PMID: 9744335 (View on PubMed)

Other Identifiers

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FPCITKR001

Identifier Type: -

Identifier Source: org_study_id

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