<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/NCT03235414</url>
  </required_header>
  <id_info>
    <org_study_id>CIN001-Liver stiffness</org_study_id>
    <nct_id>NCT03235414</nct_id>
  </id_info>
  <brief_title>Normal Liver Stiffness by MR Elastography</brief_title>
  <official_title>Determination of Normal Liver Stiffness by MR Elastography in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR&#xD;
      elastography to determine normal liver stiffness values.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring&#xD;
      of liver disease in the pediatric population. There is, however, little data specific to the&#xD;
      use of this technique in children with existing data and techniques largely extrapolated from&#xD;
      adult studies. Existing studies suggest that liver stiffness values may be different between&#xD;
      children and adults [Etchell, Xanthakos]. As such there is an unmet need for uniquely&#xD;
      pediatric data in both healthy and diseased cohorts. To address the need for such data, the&#xD;
      investigators plan a multi-site, prospective study of healthy pediatric (&lt;18 years of age)&#xD;
      volunteers to determine normal liver stiffness measured by MR elastography across the range&#xD;
      of MRI equipment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2018</start_date>
  <completion_date type="Actual">July 24, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2020</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Liver Stiffness</measure>
    <time_frame>During investigation</time_frame>
    <description>Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI.&#xD;
Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cross-platform Variability</measure>
    <time_frame>During Investigation</time_frame>
    <description>To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cross-field Strength</measure>
    <time_frame>During investigation</time_frame>
    <description>To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sex-related Differences</measure>
    <time_frame>During investigation</time_frame>
    <description>To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>Normals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive an MRI and a blood draw</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Will receive a one time research MRI (MR elastography)</description>
    <arm_group_label>Normals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>Will receive a one time blood draw to confirm healthy liver status</description>
    <arm_group_label>Normals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 7-17 years&#xD;
&#xD;
          -  No documented history of liver diseases&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NPO less than 4 hours&#xD;
&#xD;
          -  Body mass index &lt;10th or &gt; 85th percentile for age&#xD;
&#xD;
          -  Documented history of liver disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to lie still for duration of the MRI&#xD;
&#xD;
          -  Inability to breath hold for the duration of the 15-20 second MR elastography sequence&#xD;
&#xD;
          -  Standard contraindication to MRI (implanted hardware, etc.)&#xD;
&#xD;
          -  Requirement of sedation or general anesthesia for MRI&#xD;
&#xD;
          -  Abnormality of any measured liver function test&#xD;
&#xD;
          -  Liver fat fraction &gt;5% by MRI PDFF&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Trout, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>August 12, 2020</results_first_submitted>
  <results_first_submitted_qc>August 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 27, 2020</results_first_posted>
  <last_update_submitted>August 27, 2020</last_update_submitted>
  <last_update_submitted_qc>August 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03235414/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03235414/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Normals</title>
          <description>Healthy participants receive an MRI and a blood draw&#xD;
MRI: Will receive a one time research MRI (MR elastography)&#xD;
Blood draw: Will receive a one time blood draw to confirm healthy liver status</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
      <group_list>
        <group group_id="B1">
          <title>Normals</title>
          <description>Healthy participants receive an MRI and a blood draw&#xD;
MRI: Will receive a one time research MRI (MR elastography)&#xD;
Blood draw: Will receive a one time blood draw to confirm healthy liver status</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="71"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12" lower_limit="10" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </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>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Liver Stiffness</title>
        <description>Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI.&#xD;
Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE</description>
        <time_frame>During investigation</time_frame>
        <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Stiffness</title>
          <description>Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI.&#xD;
Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE</description>
          <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
          <units>kPa</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.9" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cross-platform Variability</title>
        <description>To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values</description>
        <time_frame>During Investigation</time_frame>
        <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver</description>
          </group>
        </group_list>
        <measure>
          <title>Cross-platform Variability</title>
          <description>To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values</description>
          <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
          <units>kPa</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Philips</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Siemens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cross-field Strength</title>
        <description>To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values</description>
        <time_frame>During investigation</time_frame>
        <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver</description>
          </group>
        </group_list>
        <measure>
          <title>Cross-field Strength</title>
          <description>To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values</description>
          <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
          <units>kPa</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1.5T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sex-related Differences</title>
        <description>To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values</description>
        <time_frame>During investigation</time_frame>
        <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver</description>
          </group>
        </group_list>
        <measure>
          <title>Sex-related Differences</title>
          <description>To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values</description>
          <population>Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data</population>
          <units>kPa</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During investigation</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Healthy Participants</title>
          <description>Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver</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="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
              </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="101"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Andrew Trout</name_or_title>
      <organization>Cincinnati Children's Hospital Medical Center; Department of Radiology</organization>
      <phone>513-803-3004</phone>
      <email>andrew.trout@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/NCT03235414
org study id: CIN001-Liver stiffness
nct id: NCT03235414
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR
      elastography to determine normal liver stiffness values.
MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring
      of liver disease in the pediatric population. There is, however, little data specific to the
      use of this technique in children with existing data and techniques largely extrapolated from
      adult studies. Existing studies suggest that liver stiffness values may be different between
      children and adults [Etchell, Xanthakos]. As such there is an unmet need for uniquely
      pediatric data in both healthy and diseased cohorts. To address the need for such data, the
      investigators plan a multi-site, prospective study of healthy pediatric (<18 years of age)
      volunteers to determine normal liver stiffness measured by MR elastography across the range
      of MRI equipment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Liver Stiffness
time frame: During investigation
description: Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI.
Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE
measure: Cross-platform Variability
time frame: During Investigation
description: To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values
measure: Cross-field Strength
time frame: During investigation
description: To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values
measure: Sex-related Differences
time frame: During investigation
description: To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values
arm group label: Normals
arm group type: Experimental
description: Will receive an MRI and a blood draw
intervention type: Device
intervention name: MRI
description: Will receive a one time research MRI (MR elastography)
arm group label: Normals
intervention type: Diagnostic Test
intervention name: Blood draw
description: Will receive a one time blood draw to confirm healthy liver status
arm group label: Normals
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Trout, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 