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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- diagnostic sensitivity and specificity, and acute complication
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
A
Parkinson's disease
干预措施: PET/CT (Procedure)
A
Parkinson's disease
干预措施: F-18 FPCIT (Drug)
B
ET+Normal
干预措施: PET/CT (Procedure)
B
ET+Normal
干预措施: F-18 FPCIT (Drug)
结局指标
主要结局
diagnostic sensitivity and specificity, and acute complication
时间窗: 1 month
次要结局
- correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)(10 days)
研究者
Jae Seung Kim
Professor
Asan Medical Center