<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02226666</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00075454</org_study_id>
    <nct_id>NCT02226666</nct_id>
  </id_info>
  <brief_title>Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration</brief_title>
  <official_title>Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to prospectively compare the physiologic response of patients&#xD;
      who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine&#xD;
      (MultiHance).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Contrast-enhanced hepatic MRI is an accepted method for detecting and characterizing liver&#xD;
      lesions. Liver lesion characterization is fundamental for patient management, because lesions&#xD;
      that meet specific imaging criteria for hepatocellular carcinoma (HCC) are assumed to be HCC&#xD;
      without tissue confirmation. There are a variety of gadolinium-based contrast agents that are&#xD;
      used for this purpose. Two of the more commonly utilized are gadoxetic acid (an hepatobiliary&#xD;
      contrast agent that permits 20 minute hepatobiliary phase imaging) and gadobenate dimeglumine&#xD;
      (a weak hepatobiliary contrast agent that functions generally as an extracellular contrast&#xD;
      agent). A recent study by our group has shown that patients who receive intravenous gadoxetic&#xD;
      acid are much more likely to experience transient dyspnea after contrast injection that&#xD;
      causes them to breathe rapidly through the arterial phase of imaging, degrading image&#xD;
      quality. In that study, subjective complaints of dyspnea and respiratory motion artifact on&#xD;
      imaging were scored. The investigators did not assess patient physiologic response. The goal&#xD;
      of the proposed work is to build on our prior data and to determine whether there are&#xD;
      non-invasively measurable physiologic parameters that can support our original study.&#xD;
      Specifically, the investigators want to determine whether there are predictable changes in&#xD;
      SpO2, pulse, respiratory periodicity, and respiratory regularity that correlate with arterial&#xD;
      phase image degradation and patients complains of dyspnea. Both contrast agents to be&#xD;
      assessed in this study are FDA approved with at least 4 years of post-marketing experience&#xD;
      documenting safety and efficacy. The investigators will not be changing or altering our&#xD;
      clinical approach in any way as a part of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjects fill out a short 5-question survey about their MRI experience directly following clinical MRI scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Levels</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate</measure>
    <time_frame>Baseline</time_frame>
    <description>We will monitor a subjects' respiratory rate (how many times they breathe in a minute) during the clinical MRI scan.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">107</enrollment>
  <condition>Liver Tumor</condition>
  <arm_group>
    <arm_group_label>Patients having MRI with Eovist</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients having MRI with Multihance</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MRI with Multihance</intervention_name>
    <description>Patients will have Multihance used as an IV contrast agent for their scan.</description>
    <arm_group_label>Patients having MRI with Multihance</arm_group_label>
    <other_name>gadobenate dimeglumine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MRI with Eovist</intervention_name>
    <description>Patients will have Eovist used as an IV contrast agent for their scan.</description>
    <arm_group_label>Patients having MRI with Eovist</arm_group_label>
    <other_name>Gadoxetate disodium</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One-hundred patients receiving gadoxetic acid for hepatobiliary indications and 100&#xD;
        patients receiving gadobenate dimeglumine for hepatobiliary indications will be studied&#xD;
        prospectively. All patients will be scheduled to undergo MRI for clinical purposes by their&#xD;
        primary care physicians. The patients will not be randomized.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years old and older&#xD;
&#xD;
          -  Patients scheduled for MRI examination at the University of Michigan hospital&#xD;
&#xD;
          -  Patients receiving either MultiHance or Eovist contrast agents during their clinical&#xD;
             MRI examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age&#xD;
&#xD;
          -  Patients who will not receive MultiHance or Eovist as part of their clinical MRI&#xD;
             examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Davenport, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Matthew Davenport, MD</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>Eovist</keyword>
  <keyword>MultiHance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02226666
org study id: HUM00075454
nct id: NCT02226666
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: Survey
time frame: Baseline
description: Subjects fill out a short 5-question survey about their MRI experience directly following clinical MRI scan.
measure: Oxygen Levels
time frame: Baseline
description: 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.
measure: Respiratory Rate
time frame: Baseline
description: We will monitor a subjects' respiratory rate (how many times they breathe in a minute) during the clinical MRI scan.
arm group label: Patients having MRI with Eovist
description: 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.
arm group label: Patients having MRI with Multihance
description: 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.
intervention type: Drug
intervention name: MRI with Multihance
description: Patients will have Multihance used as an IV contrast agent for their scan.
arm group label: Patients having MRI with Multihance
other name: gadobenate dimeglumine
intervention type: Drug
intervention name: MRI with Eovist
description: Patients will have Eovist used as an IV contrast agent for their scan.
arm group label: Patients having MRI with Eovist
other name: Gadoxetate disodium
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Davenport, MD
role: Principal Investigator
affiliation: University of Michigan Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Matthew Davenport, MD
investigator title: Principle Investigator
mesh term: Liver Neoplasms
sharing ipd: No