NCT04704284已完成不适用
Comparative Analysis of Zero Echo-time MRI and CT for Pediatric Craniosynostosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis
研究概览
简要总结
The purpose of this study is to develop and test the effectiveness and diagnostic quality of Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in comparison to CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients 0-18 of age will be recruited by our surgical colleagues based on the clinical concern for craniosynostosis and possible need for calvarial reconstruction.
排除标准
- •Lack of consent
- •Contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.
研究组 & 干预措施
ZTE MRI Imaging
Experimental
Pediatric patients that have gotten a clinically indicated CT within a 6 week time period will receive a Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)
干预措施: Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) (Diagnostic Test)
结局指标
主要结局
Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis
时间窗: 1 Day
In the context of our study, concordance refers to the level of agreement between two radiologists in their interpretation of imaging findings across the two modalities (ZTE and CT).
次要结局
未报告次要终点
研究者
Julie B. Guerin
Principal Investigator
Mayo Clinic
研究点 (1)
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