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临床试验/NCT02107599
NCT02107599已完成4 期

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

Avid Radiopharmaceuticals1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

发起方
Avid Radiopharmaceuticals
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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