<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/NCT04462562</url>
  </required_header>
  <id_info>
    <org_study_id>SNUH 2002-020-1099</org_study_id>
    <nct_id>NCT04462562</nct_id>
  </id_info>
  <brief_title>Quantitative US for Evaluation of Hepatic Steatosis in NAFLD</brief_title>
  <official_title>The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Samsung Medison</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate diagnostic performance of quantitative&#xD;
      ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off&#xD;
      values in patients with non-alcoholic fatty liver disease using magnetic resonance imaging&#xD;
      proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">June 29, 2021</completion_date>
  <primary_completion_date type="Actual">June 29, 2021</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>Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)</measure>
    <time_frame>1 month</time_frame>
    <description>Reference standard: MRI-proton density fat fraction or MR spectroscopy value (5 percent)&#xD;
- ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF &gt;5 percent patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)</measure>
    <time_frame>1 month</time_frame>
    <description>Reference standard: MRI-PDFF or MR spectroscopy value (10 percent, 15 percent, 15 percent, 20 percent, 25 percent)&#xD;
- ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF &gt;10, &gt;20 percent patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of QUS parameters and MR fat fraction</measure>
    <time_frame>1 month</time_frame>
    <description>reference standard: MRI-PDFF or MR spectroscopy value (percent)&#xD;
- spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-observer agreement of quantitative US parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction</measure>
    <time_frame>1 month</time_frame>
    <description>pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent)</measure>
    <time_frame>1 month</time_frame>
    <description>Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 20 percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)</measure>
    <time_frame>1 month</time_frame>
    <description>Reference standard: MRI-proton density fat fraction (5 percent)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">173</enrollment>
  <condition>Fatty Liver</condition>
  <condition>Fatty Liver, Nonalcoholic</condition>
  <arm_group>
    <arm_group_label>quantitative ultrasound imaging parameters</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>quantitative ultrasound imaging parameters&#xD;
tissue attenuation imaging (TAI) parameter&#xD;
tissue scatter-distribution imaging (TSI) parameter&#xD;
Hepatorenal index (semi-auto, EzHRI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantitative US (Samsung Medison, RS85A)</intervention_name>
    <description>In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed</description>
    <arm_group_label>quantitative ultrasound imaging parameters</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with known NAFLD or suspected of having NAFLD&#xD;
&#xD;
          -  Patients who are scheduled hepatectomy for living donor liver donation&#xD;
&#xD;
          -  aged ≥ 18 years who are willing and able to complete all procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)&#xD;
&#xD;
          -  clinical, laboratory, or histologic evidence of a liver disease other than NAFLD,&#xD;
             including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders&#xD;
&#xD;
          -  use of steatogenic or hepatotoxic medication&#xD;
&#xD;
          -  evidence of decompensated liver disease&#xD;
&#xD;
          -  history of liver surgery&#xD;
&#xD;
          -  contraindication to MRI&#xD;
&#xD;
          -  any other condition believed by investigator to affect a patients' compliance, or&#xD;
             completion of the study&#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</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>March 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</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>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</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/NCT04462562
org study id: SNUH 2002-020-1099
nct id: NCT04462562
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate diagnostic performance of quantitative
      ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off
      values in patients with non-alcoholic fatty liver disease using magnetic resonance imaging
      proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
time frame: 1 month
description: Reference standard: MRI-proton density fat fraction or MR spectroscopy value (5 percent)
- ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >5 percent patients
measure: Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)
time frame: 1 month
description: Reference standard: MRI-PDFF or MR spectroscopy value (10 percent, 15 percent, 15 percent, 20 percent, 25 percent)
- ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >10, >20 percent patients
measure: Correlation of QUS parameters and MR fat fraction
time frame: 1 month
description: reference standard: MRI-PDFF or MR spectroscopy value (percent)
- spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent)
measure: Intra-observer agreement of quantitative US parameters
time frame: 1 day
description: Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value)
measure: Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction
time frame: 1 month
description: pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction
measure: Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent)
time frame: 1 month
description: Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 20 percent)
measure: Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)
time frame: 1 month
description: Reference standard: MRI-proton density fat fraction (5 percent)
arm group label: quantitative ultrasound imaging parameters
arm group type: Experimental
description: quantitative ultrasound imaging parameters
tissue attenuation imaging (TAI) parameter
tissue scatter-distribution imaging (TSI) parameter
Hepatorenal index (semi-auto, EzHRI)
intervention type: Diagnostic Test
intervention name: Quantitative US (Samsung Medison, RS85A)
description: In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed
arm group label: quantitative ultrasound imaging parameters
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeong Min Lee
role: Study Director
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong Min Lee
investigator title: Professor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease