Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients
- Registration Number
- NCT00468078
- Lead Sponsor
- Asan Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A PET/CT Parkinson's disease A F-18 FPCIT Parkinson's disease B F-18 FPCIT ET+Normal B PET/CT ET+Normal
- Primary Outcome Measures
Name Time Method diagnostic sensitivity and specificity, and acute complication 1 month
- Secondary Outcome Measures
Name Time Method correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage) 10 days
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of