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

Study Overview
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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.

Official Title
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The Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor Patients

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Procedure: PET/CT
* Drug: F-18 FPCIT


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Parkinson's disease | Procedure: PET/CT<br>* 10min acquisition, 90min after injection of F-18 FPCIT<br>* Other names: Positron Emission Tomography;Drug: F-18 FPCIT<br>* 5mCi, intravenous injection<br>|
| Active Comparator: B<br>ET+Normal | Procedure: PET/CT<br>* 10min acquisition, 90min after injection of F-18 FPCIT<br>* Other names: Positron Emission Tomography;Drug: F-18 FPCIT<br>* 5mCi, intravenous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic sensitivity and specificity, and acute complication |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage) |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Essential tremor, F-18 FPCIT, PET