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Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration

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ClinicalTrials.gov Identifier: NCT02226666
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Matthew Davenport, MD, University of Michigan

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).

Condition or disease Intervention/treatment
Liver Tumor Drug: MRI with Multihance Drug: MRI with Eovist

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.

Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration
Study Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Drug: MRI with Eovist
Patients will have Eovist used as an IV contrast agent for their scan.
Other Name: Gadoxetate disodium

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.
Drug: MRI with Multihance
Patients will have Multihance used as an IV contrast agent for their scan.
Other Name: gadobenate dimeglumine




Primary Outcome Measures :
  1. Survey [ Time Frame: Baseline ]
    Subjects fill out a short 5-question survey about their MRI experience directly following clinical MRI scan.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
One-hundred patients receiving gadoxetic acid for hepatobiliary indications and 100 patients receiving gadobenate dimeglumine for hepatobiliary indications will be studied prospectively. All patients will be scheduled to undergo MRI for clinical purposes by their primary care physicians. The patients will not be randomized.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226666


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Matthew Davenport, MD University of Michigan Hospital

Responsible Party: Matthew Davenport, MD, Principle Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02226666     History of Changes
Other Study ID Numbers: HUM00075454
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthew Davenport, MD, University of Michigan:
MRI
Eovist
MultiHance

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases