<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/NCT02201797</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0060</org_study_id>
    <nct_id>NCT02201797</nct_id>
  </id_info>
  <brief_title>Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body</brief_title>
  <official_title>Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bracco Diagnostics, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced)&#xD;
      and DWI MRI can provide valuable information regarding tumor biology and response to&#xD;
      treatment through various parameters. Validating stability of these parameters will further&#xD;
      establish robustness and reliability of these promising biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>repeatability coefficient (RC)</measure>
    <time_frame>one year</time_frame>
    <description>Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Metastatic Liver Cancer</condition>
  <arm_group>
    <arm_group_label>DCE and DWI MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRI SCAN 1 and MRI SCAN 2 must be completed no less than 2 calendar days (to ensure 24 hours for clearance of gadolinium) and no greater than 14 days apart, and both must be completed prior to new treatment initiation. The same MRI unit and configuration must be used for MRI SCAN 1 and MRI SCAN 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DCE MRI</intervention_name>
    <arm_group_label>DCE and DWI MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of metastatic liver cancer proven by pathology&#xD;
&#xD;
          -  At least one liver tumor should be &gt; 2cm in long diameter&#xD;
&#xD;
          -  Patients with viable tumor proven in the other imaging modalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe claustrophobia&#xD;
&#xD;
          -  Presence of MRI-incompatible metallic objects or implanted medical devices in body&#xD;
&#xD;
          -  Renal failure, as determined by glomerular filtration rate (GFR) &lt; 30 mL/min/1.73 m2&#xD;
&#xD;
          -  Weight greater than that allowable by the MRI table&#xD;
&#xD;
          -  Chemotherapy within 28 days prior to enrollment&#xD;
&#xD;
          -  Prior external radiation therapy to the liver, prior transarterial chemoembolization&#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>Kyung Won Kim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>June 22, 2015</last_update_submitted>
  <last_update_submitted_qc>June 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Kyung Won Kim</investigator_full_name>
    <investigator_title>Assistance Professor</investigator_title>
  </responsible_party>
  <keyword>Reproducibility of Results</keyword>
  <keyword>Liver neoplasm</keyword>
  <keyword>Neoplasm metastasis</keyword>
  <keyword>Regional Perfusion</keyword>
  <keyword>Perfusion Magnetic Resonance Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02201797
org study id: 2014-0060
nct id: NCT02201797
lead sponsor: 
collaborator: 
has dmc: No
Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced)
      and DWI MRI can provide valuable information regarding tumor biology and response to
      treatment through various parameters. Validating stability of these parameters will further
      establish robustness and reliability of these promising biomarkers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: repeatability coefficient (RC)
time frame: one year
description: Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured.
arm group label: DCE and DWI MRI
arm group type: Experimental
description: MRI SCAN 1 and MRI SCAN 2 must be completed no less than 2 calendar days (to ensure 24 hours for clearance of gadolinium) and no greater than 14 days apart, and both must be completed prior to new treatment initiation. The same MRI unit and configuration must be used for MRI SCAN 1 and MRI SCAN 2.
intervention type: Other
intervention name: DCE MRI
arm group label: DCE and DWI MRI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyung Won Kim, M.D.
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Kyung Won Kim
investigator title: Assistance Professor
mesh term: Liver Neoplasms