Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Dotarem TTP
研究概览
简要总结
Rationale: Dotarem provides superior enhancement characteristics compared to other GBCA in fMRU
Specific Aims: Compare enhancement characteristics of Dotarem to other GBCAs in the kidneys used in fMRU
Primary Objectives: Review functional analysis curves and data of fMRU studies and determine enhancement characteristics in the kidneys of the three GBCAs (Dotarem, Gadovist, Magnevist)
详细描述
A retrospective review will be performed of all functional MRI urography (fMRU) cases at two institutions (Children's Hospital of Philadelphia and Vanderbilt Children's Hospital). Over 1000 studies have been performed between the institutions and the normal studies will be selected based on radiology reports and reviewed to confirm they are normal. The fMRU is performed with Gadolinium based contrast agents (GBCAs), initially was performed with Magnevist, then switched to Gadavist, and most recently converted to Dotarem. The fMRU software for analysis of the functional data provides enhancement curves of the aorta and kidneys. fMRU enhancement curves are generated by drawing regions of interest in the aorta and renal parenchyma and calculating the average signal intensity over time. A comparison of the enhancement curves will be performed of the three GBCAs in the normal pediatric population. The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs. The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained. Additional functional data will be reviewed such as calyceal transit time (CTT) and renal transit time (RTT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric population which obtained MRI/fMRU study
排除标准
- •Bilateral abnormal kidneys
研究组 & 干预措施
Dotarem Enhancement Group
干预措施: Dotarem (Drug)
Gadovist Enhancement Group
干预措施: Gadovist (Drug)
Magnevist Enhancement Group
干预措施: Magnevist (Drug)
结局指标
主要结局
Dotarem TTP
时间窗: 1 hour
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Gadovist TTP
时间窗: 1 hour
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Magnevist TTP
时间窗: 1 hour
The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs.
Dotarem Time of Enhancement Intensity
时间窗: 1 hour
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Gadovist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist
时间窗: 1 hour
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
Magnevist Time of Enhancement Intensity Time of Enhancement Intensity for Gadovist
时间窗: 1 hour
The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained.
次要结局
未报告次要终点
研究者
Aashim Bhatia
Assistant Professor
Vanderbilt University Medical Center
