A Study to Evaluate the Improvement in Reader Accuracy When Using a Read Method That Incorporates Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Visual Interpretation of Amyvid Brain Scans
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Reader Accuracy After Application of Quantitation Software
研究概览
简要总结
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Readers have undergone Amyvid reader training
- •Readers have not more than minimal experience with quantitation of amyloid PET scans
排除标准
- •Readers have previously been trained to quantitate amyloid PET scans
研究组 & 干预措施
Physician Readers
Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir(18F) as part of this study.
干预措施: Florbetapir (18F) (Drug)
结局指标
主要结局
Change in Reader Accuracy After Application of Quantitation Software
时间窗: Scan acquired 50-60 minutes post injection
Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values \>0 indicate an improvement in scan interpretation accuracy and values \<0 indicate a decline in scan interpretation accuracy after application of quantitation software. NRI = \[P(up,event)-P(down,event)\]-\[P(up,nonevent)-P(down,nonevent)\] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative Only the 46 scans with autopsy from A16 are used for this outcome measure.
次要结局
- Change in Scan Interpretation Reliability After Application of Quantitation Software(Scan acquired 50-60 minutes post injection)
