<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/NCT02188901</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0337</org_study_id>
    <nct_id>NCT02188901</nct_id>
  </id_info>
  <brief_title>Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study</brief_title>
  <official_title>Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma&#xD;
      (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent&#xD;
      for ultrasonography, has reported to have superior sensitivity in detecting focal liver&#xD;
      lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So&#xD;
      our aim is to compare the detection rate of early stage HCC and false referral rate of HCC&#xD;
      between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective&#xD;
      data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%)&#xD;
      than that of B-mode US (3%).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2014</start_date>
  <completion_date type="Actual">August 3, 2016</completion_date>
  <primary_completion_date type="Actual">August 3, 2016</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection rate of early stage HCC</measure>
    <time_frame>30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US</time_frame>
    <description>Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>False referral rate of HCC</measure>
    <time_frame>30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US</time_frame>
    <description>False referral rate of HCC =</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">523</enrollment>
  <condition>Hepatocellular Carcinoma (HCC)</condition>
  <arm_group>
    <arm_group_label>single arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sonazoid-enhanced ultrasonography</intervention_name>
    <description>Sonazoid (perflubutane) [GE healthcare]</description>
    <arm_group_label>single arm</arm_group_label>
    <other_name>0.015ml/kg of suspension containing 16μl of perflubutane microbubble and 2ml of diluent, IV (in the vein) on day 1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient 20 years old or older,&#xD;
&#xD;
          2. Patient at high risk of HCC and is supposed to take ultrasonography,&#xD;
&#xD;
          3. Patient who has no suspicious HCC on previous examinations or patient who undergoes&#xD;
             the first surveillance,&#xD;
&#xD;
          4. Patient who has liver cirrhosis proven by one of the following methods-liver biopsy&#xD;
             (METAVIR score 4), identification of esophageal or gastric varix by endoscopically or&#xD;
             radiologically, surface nodularity on ultrasonography, CT or MRI, platelet count less&#xD;
             than 100,000/mm3, serum albumin less than 3.5 g/dl, or prothrombin time higher than&#xD;
             1.3 INR,&#xD;
&#xD;
          5. Patient without contraindication for sonazoid,&#xD;
&#xD;
          6. Patient willing to sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient on pregnancy or breast feeding,&#xD;
&#xD;
          2. Patient with allergy to egg,&#xD;
&#xD;
          3. Patient with left-to-right shunt, respiratory insufficiency, or severe pulmonary&#xD;
             hypertension,&#xD;
&#xD;
          4. Patient with history of HCC,&#xD;
&#xD;
          5. Patient with history of malignancy other than HCC -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>April 24, 2018</last_update_submitted>
  <last_update_submitted_qc>April 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCC</keyword>
  <keyword>Sonazoid</keyword>
  <keyword>Ultrasonography</keyword>
  <keyword>Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</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/NCT02188901
org study id: 4-2014-0337
nct id: NCT02188901
lead sponsor: 
collaborator: 
has dmc: Yes
B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma
      (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent
      for ultrasonography, has reported to have superior sensitivity in detecting focal liver
      lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So
      our aim is to compare the detection rate of early stage HCC and false referral rate of HCC
      between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective
      data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%)
      than that of B-mode US (3%).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Detection rate of early stage HCC
time frame: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US
description: Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100
measure: False referral rate of HCC
time frame: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US
description: False referral rate of HCC =
arm group label: single arm
arm group type: Other
intervention type: Other
intervention name: Sonazoid-enhanced ultrasonography
description: Sonazoid (perflubutane) [GE healthcare]
arm group label: single arm
other name: 0.015ml/kg of suspension containing 16μl of perflubutane microbubble and 2ml of diluent, IV (in the vein) on day 1
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular