Safety and Diagnostic Performance of 18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Semiquantitative assessment of lesions and biodistribution
研究概览
简要总结
This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 18F-S16 in healthy volunteers and patients with neurodegenerative dementia.
详细描述
For interests in clinical translation of 18F-S16, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 18F-S16 in patients with neurodegenerative dementia. A single dose of nearly 370 MBq 18F-S16 will be intravenously injected into healthy volunteers and patients with neurodegenerative dementia. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the subjects. Adverse events will also be observed in the subjects.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Neurodegenerative Dementia
- •Males and females, ≥40 years old
- •They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.
排除标准
- •Females planning to bear a child recently or with childbearing potential
- •Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
- •Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
- •Known severe allergy or hypersensitivity to IV radiographic contrast.
- •Patients not able to enter the bore of the PET/CT scanner.
- •Inability to lie still for the entire imaging time because of cough, pain, etc.
- •Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- •Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
研究组 & 干预措施
18F-S16 injection and PET/CT scan
The subjects were intravenously injected with 370MBq 18F-S16 and underwent PET/CT scan immediately after the injection.
干预措施: 18F-S16 (Drug)
结局指标
主要结局
Semiquantitative assessment of lesions and biodistribution
时间窗: One year
The semiquantitative analysis will be performed by the same physician for all the cases, and the standardized uptake values (SUVs) of brain and other organs will be measured.
次要结局
- Blood pressure(24 hours)
- Temperature(24 hours)
- Serum creatinine(24 hours)
- Adverse events collection(5 days)
- Pulse(24 hours)
- Respiration frequency(24 hours)
- Serum alanine aminotransferase(24 hours)
- Serum albumin(24 hours)