A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F]AV- 133 in Parkinson's Disease [Dual PET AV-133 in PD]
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of tracer uptake between two cameras using Standardized Uptake Value Ratio (SUVR)
研究概览
简要总结
The study is a longitudinal, single-center study to assess progression of [18F]AV-133 imaging in PD participants. Participants will be followed for up to 12 months. Approximately 45 PD participants and 5 healthy control participants will be recruited from the ongoing PPMI Clinical 002 study. Participants will be comprehensively assessed at Baseline and follow up according to the Schedule of Activities. Participants will undergo PET imaging assessments with [18F]AV-133. After tracer injection, participants will be imaged on PET cameras at each imaging timepoint-one with the NX camera and one with a standard PET camera-in accordance with the Image Acquisition Protocol (IAP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants over the age of 18 who are enrolled in the PPMI Clinical protocol with a diagnosis of Parkinson's disease (PD) or Healthy Control participants enrolled in the PPMI Clinical protocol.
- •Able to provide informed consent.
- •Male or Female (females must meet additional criteria specified below as applicable)
- •Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of [18F]AV-133
- •Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
- •Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
- •Females of childbearing potential must not be pregnant, breastfeeding or lactating.
- •Includes a negative urine pregnancy test prior to injection of [18F]AV-133 on day of PET scan.
排除标准
- •Received any of the following medications that might interfere with [18F]AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline [18F]AV-133 injection.
- •Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
研究组 & 干预措施
Parkinson's Disease & Healthy Controls
干预措施: [18F]AV-133 (Drug)
结局指标
主要结局
Comparison of tracer uptake between two cameras using Standardized Uptake Value Ratio (SUVR)
时间窗: 12 months
To compare longitudinal change in \[18F\]AV-133 PET SUVR in the striatum and other brain regions acquired with NeuroEXPLORER (NX) camera to that acquired with Siemens Biograph camera.
次要结局
未报告次要终点