<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/NCT03260660</url>
  </required_header>
  <id_info>
    <org_study_id>CIN_CompMRE_001</org_study_id>
    <nct_id>NCT03260660</nct_id>
  </id_info>
  <brief_title>Comparison of MR Elastography Methods Without and With Compressed Sensing</brief_title>
  <official_title>Comparison of MR Elastography Methods Without and With Compressed Sensing</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this research study, the investigators will compare the liver stiffness results obtained&#xD;
      from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained&#xD;
      from a method that uses faster imaging techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MR elastography is increasingly used to assess liver stiffness in pediatric and adult&#xD;
      patients with chronic liver diseases. While numerous tissue abnormalities can affect liver&#xD;
      stiffness, liver stiffness measured by MR elastography is most often used to predict and&#xD;
      quantify liver fibrosis. Conventional MR elastography techniques require multiple&#xD;
      breath-holds that are 12-20 seconds in length. In the pediatric population, reliable&#xD;
      breath-holding &gt;10 seconds can be challenging. Recently, compressed sensing has become&#xD;
      available as a method for accelerating image data acquisition, and thus shortening&#xD;
      breath-holds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</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>Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5)</measure>
    <time_frame>30 minutes</time_frame>
    <description>Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 1.5 times the amount of standard Sensing applied. Correlation Coefficient will be determined for resulting elastography data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x2)</measure>
    <time_frame>30 minutes</time_frame>
    <description>Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 2 times the amount of standard sensing applied. correlation coefficient will be determined for resulting elastography data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x3)</measure>
    <time_frame>30 minutes</time_frame>
    <description>Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 3 times the amount of standard Sensing applied. Correlation coefficient will be determined for resulting elastography data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Standard Magnetic Resonance Elastography versus respiratory triggered Magnetic Resonance Elastography.</measure>
    <time_frame>30 minutes</time_frame>
    <description>Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography acquired using respiratory triggered Gradient Recalled Elastography. Correlation coefficient will be determined for resulting elastography data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard Magnetic Resonance Elastography versus navigated triggered Magnetic Resonance Elastography.</measure>
    <time_frame>30 minutes</time_frame>
    <description>Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography acquired using navigated triggered Gradient Recalled Elastography. Correlation coefficient will be determined for resulting elastography data.</description>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Liver Diseases</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic Resonance Elastography</intervention_name>
    <description>The investigators plan to prospectively assess the agreement of liver stiffness measurements obtained using standard of care MR elastography techniques vs. MR elastography with varying amounts of imaging acceleration using compressed sensing in adult volunteers</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult volunteers ≥18 years of age&#xD;
&#xD;
          -  Ability to tolerate 30 minutes in an MRI scanner.&#xD;
&#xD;
          -  Nothing to eat or drink for 4 hours prior to the MRI scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No contraindication to MR imaging (e.g., implanted non-MRI compatible device)&#xD;
&#xD;
          -  Known or suspected pregnancy. Female subjects of child bearing potential will undergo&#xD;
             a urine pregnancy test prior to imaging.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Dillman, MD,MSc</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>January 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</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>
  <!-- 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/NCT03260660
org study id: CIN_CompMRE_001
nct id: NCT03260660
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
In this research study, the investigators will compare the liver stiffness results obtained
      from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained
      from a method that uses faster imaging techniques.
MR elastography is increasingly used to assess liver stiffness in pediatric and adult
      patients with chronic liver diseases. While numerous tissue abnormalities can affect liver
      stiffness, liver stiffness measured by MR elastography is most often used to predict and
      quantify liver fibrosis. Conventional MR elastography techniques require multiple
      breath-holds that are 12-20 seconds in length. In the pediatric population, reliable
      breath-holding >10 seconds can be challenging. Recently, compressed sensing has become
      available as a method for accelerating image data acquisition, and thus shortening
      breath-holds.
observational model: Cohort
time perspective: Prospective
measure: Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5)
time frame: 30 minutes
description: Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 1.5 times the amount of standard Sensing applied. Correlation Coefficient will be determined for resulting elastography data.
measure: Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x2)
time frame: 30 minutes
description: Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 2 times the amount of standard sensing applied. correlation coefficient will be determined for resulting elastography data.
measure: Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x3)
time frame: 30 minutes
description: Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 3 times the amount of standard Sensing applied. Correlation coefficient will be determined for resulting elastography data.
measure: Standard Magnetic Resonance Elastography versus respiratory triggered Magnetic Resonance Elastography.
time frame: 30 minutes
description: Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography acquired using respiratory triggered Gradient Recalled Elastography. Correlation coefficient will be determined for resulting elastography data.
measure: Standard Magnetic Resonance Elastography versus navigated triggered Magnetic Resonance Elastography.
time frame: 30 minutes
description: Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography acquired using navigated triggered Gradient Recalled Elastography. Correlation coefficient will be determined for resulting elastography data.
intervention type: Device
intervention name: Magnetic Resonance Elastography
description: The investigators plan to prospectively assess the agreement of liver stiffness measurements obtained using standard of care MR elastography techniques vs. MR elastography with varying amounts of imaging acceleration using compressed sensing in adult volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Dillman, MD,MSc
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