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OpenTrials
Completed

NCT Number: NCT02226666

Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

MRI with Multihance

Drug

Patients will have Multihance used as an IV contrast agent for their scan.

Other names: gadobenate dimeglumine

MRI with Eovist

Drug

Patients will have Eovist used as an IV contrast agent for their scan.

Other names: Gadoxetate disodium

Primary outcomes

  1. Survey

    Time frame: Baseline

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

Secondary outcomes

  1. Oxygen Levels

    Time frame: Baseline

    We will monitor a subjects' oxygen levels by placing a small monitor on one of their fingers before and after the MRI; lasting approximately one minute each.

  2. Respiratory Rate

    Time frame: Baseline

    We will monitor a subjects' respiratory rate (how many times they breathe in a minute) during the clinical MRI scan.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2014
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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