<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/NCT04494022</url>
  </required_header>
  <id_info>
    <org_study_id>2004-035-1116</org_study_id>
    <nct_id>NCT04494022</nct_id>
  </id_info>
  <brief_title>Role of CEUS as a Secondary Diagnostic Modality</brief_title>
  <official_title>Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging&#xD;
      modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma&#xD;
      (HCC) among at-risks observations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to&#xD;
      identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS&#xD;
      as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All participants underwent CEUS. The image reviews based on cross-section images will be performed with or without CEUS results. Two image sets (cross-sectional image with CEUS and without CEUS) will be compared.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation</measure>
    <time_frame>1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.</time_frame>
    <description>Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.</measure>
    <time_frame>1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.</time_frame>
    <description>Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparing image characters between two types of ultrasound contrast media</measure>
    <time_frame>For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.</time_frame>
    <description>Comparing image characters between two types of ultrasound contrast media</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Cross-sectional image only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Image set which consists of a Cross-sectional image only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross-sectional image with CEUS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>contrast enhanced ultrasound</intervention_name>
    <description>Perflubutane enhanced ultrasound for evaluating hepatic tumor</description>
    <arm_group_label>Cross-sectional image with CEUS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS)&#xD;
&#xD;
          -  at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance&#xD;
             using US, CT or MRI&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congestive hepatopathies&#xD;
&#xD;
          -  severe cardiovascular dysfunction&#xD;
&#xD;
          -  no recent cross-sectional images within 4 weeks&#xD;
&#xD;
          -  suboptimal cross-sectional images quality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong Min Lee, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyo-Jin Kang, M.D.</last_name>
    <phone>82220723107</phone>
    <email>dr.kanghj@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hyun-Hee Lee, B.S.</last_name>
    <phone>82220723107</phone>
    <email>redlion55@naver.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jeong Min Lee, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong Min Lee</investigator_full_name>
    <investigator_title>Pf.</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>For two years after publication.</ipd_time_frame>
    <ipd_access_criteria>except you want to use illegal purpose</ipd_access_criteria>
  </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/NCT04494022
org study id: 2004-035-1116
nct id: NCT04494022
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging
      modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma
      (HCC) among at-risks observations.
The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to
      identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS
      as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: All participants underwent CEUS. The image reviews based on cross-section images will be performed with or without CEUS results. Two image sets (cross-sectional image with CEUS and without CEUS) will be compared.
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation
time frame: 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.
description: Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.
measure: Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.
time frame: 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.
description: Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.
measure: Comparing image characters between two types of ultrasound contrast media
time frame: For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.
description: Comparing image characters between two types of ultrasound contrast media
arm group label: Cross-sectional image only
arm group type: No Intervention
description: Image set which consists of a Cross-sectional image only.
arm group label: Cross-sectional image with CEUS
arm group type: Active Comparator
description: The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS.
intervention type: Diagnostic Test
intervention name: contrast enhanced ultrasound
description: Perflubutane enhanced ultrasound for evaluating hepatic tumor
arm group label: Cross-sectional image with CEUS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeong Min Lee, M.D.
role: Study Director
affiliation: Seoul National University
last name: Hyo-Jin Kang, M.D.
phone: 82220723107
email: dr.kanghj@gmail.com
last name: Hyun-Hee Lee, B.S.
phone: 82220723107
email: redlion55@naver.com
facility: 
status: Recruiting
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong Min Lee
investigator title: Pf.
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Yes
ipd info type: Study Protocol
ipd time frame: For two years after publication.
ipd access criteria: except you want to use illegal purpose