Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration



Status:Completed
Conditions:Liver Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/14/2017
Start Date:August 2013
End Date:December 2015

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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).

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.

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
We found this trial at
1
site
Ann Arbor, Michigan 48109
Phone: 734-232-2095
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Ann Arbor, MI
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