The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative 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 Total Accuracy (MIMNeuro Software, Low Accuracy Readers)
研究概览
简要总结
The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 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 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 F 18 as part of this study.
干预措施: Florbetapir F18 (Drug)
结局指标
主要结局
Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)
时间窗: Scan acquired 50-60 min post-injection
Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)
时间窗: Scan acquired 50-60 min post-injection
Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
次要结局
- Change in Total Accuracy (MIMNeuro Software, All Readers)(Scan acquired 50-60 min post-injection)
- Change in Reliability (MIMNeuro Software)(Scan acquired 50-60 min post-injection)
- Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)(Scan acquired 50-60 min post-injection)
- Change in Reliability (Siemens Syngo.PET Software)(Scan acquired 50-60 min post-injection)