Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Evaluation of Inter-reader Reliability Using Images From Subjects With a Clinical Presentation of AD or MCI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Inter-reader Agreement - Median Kappa Statistic
研究概览
简要总结
Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
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
- Single
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Have a history or current diagnosis of other neurologic disease
- •Have had or currently have a diagnosis of other neurodegenerative disease
- •Have participated in experimental therapy targeted to amyloid plaque
- •Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans
研究组 & 干预措施
Independent, blinded reader trainees
Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.
干预措施: florbetapir F 18 (Drug)
结局指标
主要结局
Inter-reader Agreement - Median Kappa Statistic
时间窗: 50-60 min after injection
Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.
次要结局
- Overall Inter-reader Agreement - Fleiss' Kappa(50-60 min after injection)