Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Diagnostic Performance
研究概览
简要总结
In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through [18F]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of [11C]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications.
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
- 49 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 45 and 90 years old; No gender limitation. Brain MRI supported the diagnosis of neurodegeneration, and there was no evidence of other neurological diseases.
- •Informed consent signed in person by the subject or his legal guardian or caregiver.
排除标准
- •Have other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases.
- •Received an experimental drug or device within 1 month (whose efficacy or safety is unclear).
- •patients who were unwilling to undergo PET/CT scans. pregnancy.
结局指标
主要结局
Diagnostic Performance
时间窗: Through study completion, an average of 1 year
Diagnostic performance including sensitivity, specificity, accuracy
次要结局
- Clinical Stage(Through study completion, an average of 1 year)