<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/NCT02201472</url>
  </required_header>
  <id_info>
    <org_study_id>2014-3065</org_study_id>
    <nct_id>NCT02201472</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Elastography in Infants</brief_title>
  <acronym>MREI</acronym>
  <official_title>Magnetic Resonance Elastography in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MRI &amp; MRE in infants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the present pilot study is to determine the feasibility of using MRI and MRE&#xD;
      to evaluate the liver in infants with suspected liver disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change of research focus&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Magnetic resonance elastography on infants with suspected liver disease</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Liver Disease</condition>
  <arm_group>
    <arm_group_label>MRI with MRE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI with MRE</intervention_name>
    <description>Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device</description>
    <arm_group_label>MRI with MRE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants &lt; 6 months of age&#xD;
&#xD;
          -  Known liver disease based (liver enzymes, bilirubin, and/or GGT at least twice the&#xD;
             upper limit of normal for age)&#xD;
&#xD;
          -  Parental/LAR permission obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology&#xD;
&#xD;
          -  Severe coagulopathy (INR &gt; 3 or platelets &lt;50,000)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie Merhar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>August 17, 2020</results_first_submitted>
  <results_first_submitted_qc>August 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2020</results_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>liver</keyword>
  <keyword>mre</keyword>
  <keyword>mri</keyword>
  <keyword>neonatal</keyword>
  <keyword>mr touch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MRI With MRE</title>
          <description>Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device&#xD;
MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study closed due to low enrollment. The two participants that were enrolled did not have their data analyzed.</population>
      <group_list>
        <group group_id="B1">
          <title>MRI With MRE</title>
          <description>Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device&#xD;
MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>months</units>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population</title>
        <description>To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.</description>
        <time_frame>12 months</time_frame>
        <population>There were too few eligible candidates that clinically would benefit enough to justify the potential risk of being removed from the unit and undergoing MRE in a Radiology department scanner, so the study was terminated with only 2 patients enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>MRI With MRE</title>
            <description>Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device&#xD;
MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population</title>
          <description>To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.</description>
          <population>There were too few eligible candidates that clinically would benefit enough to justify the potential risk of being removed from the unit and undergoing MRE in a Radiology department scanner, so the study was terminated with only 2 patients enrolled.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MRI With MRE</title>
          <description>Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device&#xD;
MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to difficulty with finding neonates who met the inclusion/exclusion criteria who were safe to leave the NICU and go to the Radiology department, the study was terminated and data from the 2 participants enrolled was not analyzed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Stephanie Merhar</name_or_title>
      <organization>Cincinnati Children's Hospital</organization>
      <phone>513-803-5180</phone>
      <email>stephanie.merhar@cchmc.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02201472
org study id: 2014-3065
nct id: NCT02201472
lead sponsor: 
has dmc: No
MRI & MRE in infants
The purpose of the present pilot study is to determine the feasibility of using MRI and MRE
      to evaluate the liver in infants with suspected liver disease.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Magnetic resonance elastography on infants with suspected liver disease
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population
time frame: 12 months
description: To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.
arm group label: MRI with MRE
arm group type: Experimental
description: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
intervention type: Device
intervention name: MRI with MRE
description: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
arm group label: MRI with MRE
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Stephanie Merhar, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
responsible party type: Sponsor
mesh term: Liver Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to difficulty with finding neonates who met the inclusion/exclusion criteria who were safe to leave the NICU and go to the Radiology department, the study was terminated and data from the 2 participants enrolled was not analyzed.
point of contact: 