Skip to content

Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration

Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02226666
Enrollment
107
Registered
2014-08-27
Start date
2013-08-31
Completion date
2015-12-31
Last updated
2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Tumor

Keywords

MRI, Eovist, MultiHance

Brief summary

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).

Detailed description

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.

Interventions

DRUGMRI with Multihance

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

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

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Oxygen LevelsBaselineWe 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.
Respiratory RateBaselineWe will monitor a subjects' respiratory rate (how many times they breathe in a minute) during the clinical MRI scan.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026