Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
研究概览
简要总结
This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in research participants with Parkinson's disease.
详细描述
The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.
After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain.
Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.
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
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age
- •Normal screening laboratory studies
- •At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment
排除标准
- •Pregnancy
- •Significant medical disease including abnormalities found on screening
结局指标
主要结局
CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
次要结局
- Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred