<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/NCT02242786</url>
  </required_header>
  <id_info>
    <org_study_id>2013-07-174-003</org_study_id>
    <nct_id>NCT02242786</nct_id>
  </id_info>
  <brief_title>Diffusion-Weighted Magnetic Resonance Imaging</brief_title>
  <official_title>Response Assessment for External Beam Radiation Therapy in Spinal Metastasis of Hepatocellular Carcinoma (HCC): Usefulness of Diffusion-Weighted Magnetic Resonance (MR) Imaging as A Functional Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic&#xD;
      applications. Especially, it is expected the DW MRI could provide valuable information about&#xD;
      early response evaluation after treatment using rapid apparent diffusion coefficient (ADC)&#xD;
      value change. It has demonstrated potential usefulness in response evaluation in the liver&#xD;
      tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy&#xD;
      (RT). Furthermore, it is a functional imaging technique that does not require a contrast&#xD;
      agent, it can be safely used in patients with renal insufficiency or other medical&#xD;
      contraindications for contrast agents.&#xD;
&#xD;
      The optimal assessment of early response of RT could provide one of the most important&#xD;
      information to prescribe patient and cancer specific RT dose. It might be also important in&#xD;
      palliative RT of HCC bone metastasis which is related with painful aggressive mass formation.&#xD;
&#xD;
      This study is performed to evaluate the usefulness of DW MRI in early response evaluation&#xD;
      after RT for HCC bone metastasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Phase 2</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>oral morphine equivalent doseresponse criteria</measure>
    <time_frame>3 months after RT completion</time_frame>
    <description>Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Response Evaluation Criteria in Solid Tumor</measure>
    <time_frame>3 months after RT completion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to local tumor progression</measure>
    <time_frame>From RT start to the date up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From RT start to the date up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>3 months after RT completion</time_frame>
    <description>Quality of life will be assessed via European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire (QLQ)-C15-PAL.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">17</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Spine Metastasis</condition>
  <arm_group>
    <arm_group_label>EBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>External beam radiation therapy</intervention_name>
    <arm_group_label>EBRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hepatocellular carcinoma&#xD;
&#xD;
          -  Spine metastasis&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3&#xD;
&#xD;
          -  20 or older age&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  consent to birth control during 6 months after treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 12 weeks of expected survival&#xD;
&#xD;
          -  indication of emergency operation&#xD;
&#xD;
          -  uncontrolled ascites or encephalopathy&#xD;
&#xD;
          -  previous RT field lesion (within in 1 month)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Won Park, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jong Won Kwon, MD, PhD</last_name>
    <phone>82-2-3410-2548</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jong Won Park, M.D., Ph.D.</last_name>
      <phone>82-2-3410-2548</phone>
    </contact>
    <investigator>
      <last_name>Hee Chul Park, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeong Il Yu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>November 6, 2014</last_update_submitted>
  <last_update_submitted_qc>November 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jong Won Kwon</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</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/NCT02242786
org study id: 2013-07-174-003
nct id: NCT02242786
lead sponsor: 
has dmc: Yes
Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic
      applications. Especially, it is expected the DW MRI could provide valuable information about
      early response evaluation after treatment using rapid apparent diffusion coefficient (ADC)
      value change. It has demonstrated potential usefulness in response evaluation in the liver
      tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy
      (RT). Furthermore, it is a functional imaging technique that does not require a contrast
      agent, it can be safely used in patients with renal insufficiency or other medical
      contraindications for contrast agents.

      The optimal assessment of early response of RT could provide one of the most important
      information to prescribe patient and cancer specific RT dose. It might be also important in
      palliative RT of HCC bone metastasis which is related with painful aggressive mass formation.

      This study is performed to evaluate the usefulness of DW MRI in early response evaluation
      after RT for HCC bone metastasis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: oral morphine equivalent doseresponse criteria
time frame: 3 months after RT completion
description: Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).
measure: Modified Response Evaluation Criteria in Solid Tumor
time frame: 3 months after RT completion
measure: Time to local tumor progression
time frame: From RT start to the date up to 24 weeks
measure: Overall survival
time frame: From RT start to the date up to 24 weeks
measure: Quality of Life
time frame: 3 months after RT completion
description: Quality of life will be assessed via European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire (QLQ)-C15-PAL.
arm group label: EBRT
arm group type: Experimental
intervention type: Radiation
intervention name: External beam radiation therapy
arm group label: EBRT
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jong Won Park, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Jong Won Kwon, MD, PhD
phone: 82-2-3410-2548
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jong Won Kwon
investigator title: Assistant Professor
mesh term: Carcinoma
mesh term: Neoplasm Metastasis
mesh term: Carcinoma, Hepatocellular