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临床试验/NCT02226666
NCT02226666已完成不适用

Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration

University of Michigan1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2013年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
1
主要终点
Survey

研究概览

简要总结

The purpose of this study is to prospectively compare the physiologic response of patients who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine (MultiHance).

详细描述

Contrast-enhanced hepatic MRI is an accepted method for detecting and characterizing liver lesions. Liver lesion characterization is fundamental for patient management, because lesions that meet specific imaging criteria for hepatocellular carcinoma (HCC) are assumed to be HCC without tissue confirmation. There are a variety of gadolinium-based contrast agents that are used for this purpose. Two of the more commonly utilized are gadoxetic acid (an hepatobiliary contrast agent that permits 20 minute hepatobiliary phase imaging) and gadobenate dimeglumine (a weak hepatobiliary contrast agent that functions generally as an extracellular contrast agent). A recent study by our group has shown that patients who receive intravenous gadoxetic acid are much more likely to experience transient dyspnea after contrast injection that causes them to breathe rapidly through the arterial phase of imaging, degrading image quality. In that study, subjective complaints of dyspnea and respiratory motion artifact on imaging were scored. The investigators did not assess patient physiologic response. The goal of the proposed work is to build on our prior data and to determine whether there are non-invasively measurable physiologic parameters that can support our original study. Specifically, the investigators want to determine whether there are predictable changes in SpO2, pulse, respiratory periodicity, and respiratory regularity that correlate with arterial phase image degradation and patients complains of dyspnea. Both contrast agents to be assessed in this study are FDA approved with at least 4 years of post-marketing experience documenting safety and efficacy. The investigators will not be changing or altering our clinical approach in any way as a part of this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years old and older
  • Patients scheduled for MRI examination at the University of Michigan hospital
  • Patients receiving either MultiHance or Eovist contrast agents during their clinical MRI examination

排除标准

  • Patients under 18 years of age
  • Patients who will not receive MultiHance or Eovist as part of their clinical MRI examination

研究组 & 干预措施

Patients having MRI with Eovist

Subjects having a clinically ordered MRI with Eovist. Patients consenting for the study will be monitored before and after getting MRI contrast. For the study oxygen saturation (amount of oxygen level in the blood) and breathing will be monitored during the can. Breathing will be measured with a non-invasive respiratory monitoring device attached to the MR scanner. Each patient will answer survey questions after the scan about their experiences concerning MRI contrast.

干预措施: MRI with Eovist (Drug)

Patients having MRI with Multihance

Subjects having a clinically ordered MRI with Multihance. Patients consenting for the study will be monitored before and after getting MRI contrast. For the study oxygen saturation (amount of oxygen level in the blood) and breathing will be monitored during the scan. Breathing will be measured with a non-invasive respiratory monitoring device attached to the MR scanner. Each patient will answer survey questions after the scan about their experiences concerning MRI contrast.

干预措施: MRI with Multihance (Drug)

结局指标

主要结局

Survey

时间窗: Baseline

Subjects fill out a short 5-question survey about their MRI experience directly following clinical MRI scan.

次要结局

  • Oxygen Levels(Baseline)
  • Respiratory Rate(Baseline)

研究者

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

Matthew Davenport, MD

Principle Investigator

University of Michigan

研究点 (1)

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