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临床试验/NCT03910114
NCT03910114已完成不适用

Contrast Enhancement Characteristics of Gadolinium-Based-Contrast-Agents (GBCA) in Functional MR Urography (fMRU)

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 1990年7月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aashim Bhatia

Assistant Professor

Vanderbilt University Medical Center

研究点 (2)

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