Overview

This trial is active, not recruiting.

Condition liver tumor
Treatments mri with multihance, mri with eovist
Sponsor University of Michigan
Start date August 2013
End date December 2016
Trial size 107 participants
Trial identifier NCT02226666, HUM00075454

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
mri with eovist Gadoxetate disodium
Patients will have Eovist used as an IV contrast agent for their scan.
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.
mri with multihance gadobenate dimeglumine
Patients will have Multihance used as an IV contrast agent for their scan.

Primary Outcomes

Measure
Survey
time frame: Baseline

Secondary Outcomes

Measure
Oxygen Levels
time frame: Baseline
Respiratory Rate
time frame: Baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration
Principal investigator Matthew Davenport, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Michigan.