xml: <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/NCT05986916</url>
    </required_header>
    <id_info>
      <org_study_id>806222</org_study_id>
      <nct_id>NCT05986916</nct_id>
    </id_info>
    <brief_title>Accurate Point of Care Liver Disease Diagnostics</brief_title>
    <official_title>Accurate Point of Care Liver Disease Diagnostics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Diego</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Livivos, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Diego</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This research study is being conducted to find out more about techniques to non-invasively&#xD;
        evaluate liver disease. The investigators are testing a new technology to evaluate the liver&#xD;
        (LiverScope®), and they will compare it to other methods to evaluate the liver, including&#xD;
        advanced conventional liver MR and liver FibroScan® ultrasound exams. MR exams and FibroScan®&#xD;
        ultrasound exams are common exams used to monitor NAFLD. Conventional MR scanners use&#xD;
        magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small,&#xD;
        portable MR-based device that uses similar, but simplified technology, and can be used on top&#xD;
        of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical&#xD;
        use.&#xD;
  &#xD;
        In this study the investigators will learn how LiverScope® measurements of the liver compare&#xD;
        to MR.&#xD;
  &#xD;
        Study participants will be asked to complete a one-time visit which includes:&#xD;
  &#xD;
          -  LiverScope exam&#xD;
  &#xD;
          -  MR exam&#xD;
  &#xD;
          -  FibroScan exam (optional)&#xD;
  &#xD;
          -  Blood draw&#xD;
  &#xD;
          -  Completion of study questionnaires&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 3, 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Repeatability and reproducibility coefficients of LiverScope® PDFF measurements</measure>
      <time_frame>Up to 3 months</time_frame>
      <description>Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of LiverScope® PDFF measurements with MRI PDFF measurements</measure>
      <time_frame>Up to 3 months</time_frame>
      <description>Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Repeatability and reproducibility coefficients of LiverScope® T1 measurements</measure>
      <time_frame>Up to 3 months</time_frame>
      <description>Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements</measure>
      <time_frame>Up to 3 months</time_frame>
      <description>Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>NAFLD</condition>
    <condition>Nonalcoholic Fatty Liver</condition>
    <arm_group>
      <arm_group_label>Single arm</arm_group_label>
      <description>This is a single arm study in which all participants undergo the same research procedures.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Liverscope® exam</intervention_name>
      <description>Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).</description>
      <arm_group_label>Single arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>MR exam</intervention_name>
      <description>Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.</description>
      <arm_group_label>Single arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>FibroScan® exam (optional)</intervention_name>
      <description>Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.</description>
      <arm_group_label>Single arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood draw</intervention_name>
      <description>Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.</description>
      <arm_group_label>Single arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Body measurements</intervention_name>
      <description>Participants will have their height, weight, waist circumference, and hip circumference measured.</description>
      <arm_group_label>Single arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaires</intervention_name>
      <description>Participants will be asked to fill out questionnaires to collect information about their alcohol consumption, history of cigarette smoking, presence of diabetes, and history of liver disease and medications</description>
      <arm_group_label>Single arm</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with clinically known or suspected liver disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age:18 years or older&#xD;
  &#xD;
            -  Known or clinically suspected NAFLD&#xD;
  &#xD;
            -  Weight less than 350 lbs (safety limit of MR scanner table)&#xD;
  &#xD;
            -  Able to lie on LiverScope® diagnostic table for about 15 min&#xD;
  &#xD;
            -  Able to hold breath repeatedly for about 20 s during MR and LiverScope® exams&#xD;
  &#xD;
            -  Willing and able to undergo all study procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  VA patient only; not a UCSD patient&#xD;
  &#xD;
            -  UCSD or Livivos study personnel&#xD;
  &#xD;
            -  MR contraindication(s)&#xD;
  &#xD;
            -  Potential participant states that she knows that she is pregnant, thinks she may be&#xD;
               pregnant or states she is trying to become pregnant*&#xD;
  &#xD;
            -  Known chronic liver disease other than NAFLD&#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>Claude B Sirlin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Diego</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yesenia Covarrubias</last_name>
      <phone>8582462198</phone>
      <email>ycovarrubias@health.ucsd.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lael Ceriani</last_name>
      <phone>8582462193</phone>
      <email>lceriani@health.ucsd.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California San Diego</name>
        <address>
          <city>La Jolla</city>
          <state>California</state>
          <zip>92037</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yesenia Covarrubias</last_name>
        <phone>858-246-2198</phone>
        <email>ycovarrubias@health.ucsd.edu</email>
      </contact>
      <contact_backup>
        <last_name>Lael Ceriani</last_name>
        <phone>8582462193</phone>
        <email>lceriani@health.ucsd.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Claude B Sirlin, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, San Diego</investigator_affiliation>
      <investigator_full_name>Claude Sirlin</investigator_full_name>
      <investigator_title>Professor of Radiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>This is an SBIR study. De-identified coded data will be shared as per grant application.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>One year after completion</ipd_time_frame>
      <ipd_access_criteria>Public</ipd_access_criteria>
      <ipd_url>https://library.ucsd.edu/dc</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986916
  org study id: 806222
  nct id: NCT05986916
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  This research study is being conducted to find out more about techniques to non-invasively
        evaluate liver disease. The investigators are testing a new technology to evaluate the liver
        (LiverScope®), and they will compare it to other methods to evaluate the liver, including
        advanced conventional liver MR and liver FibroScan® ultrasound exams. MR exams and FibroScan®
        ultrasound exams are common exams used to monitor NAFLD. Conventional MR scanners use
        magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small,
        portable MR-based device that uses similar, but simplified technology, and can be used on top
        of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical
        use.
  
        In this study the investigators will learn how LiverScope® measurements of the liver compare
        to MR.
  
        Study participants will be asked to complete a one-time visit which includes:
  
          -  LiverScope exam
  
          -  MR exam
  
          -  FibroScan exam (optional)
  
          -  Blood draw
  
          -  Completion of study questionnaires
  observational model: Cohort
  time perspective: Prospective
  measure: Repeatability and reproducibility coefficients of LiverScope® PDFF measurements
  time frame: Up to 3 months
  description: Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®.
  measure: Agreement of LiverScope® PDFF measurements with MRI PDFF measurements
  time frame: Up to 3 months
  description: Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.
  measure: Repeatability and reproducibility coefficients of LiverScope® T1 measurements
  time frame: Up to 3 months
  description: Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®.
  measure: Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements
  time frame: Up to 3 months
  description: Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements.
  arm group label: Single arm
  description: This is a single arm study in which all participants undergo the same research procedures.
  intervention type: Diagnostic Test
  intervention name: Liverscope® exam
  description: Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).
  arm group label: Single arm
  intervention type: Diagnostic Test
  intervention name: MR exam
  description: Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
  arm group label: Single arm
  intervention type: Diagnostic Test
  intervention name: FibroScan® exam (optional)
  description: Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.
  arm group label: Single arm
  intervention type: Other
  intervention name: Blood draw
  description: Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.
  arm group label: Single arm
  intervention type: Other
  intervention name: Body measurements
  description: Participants will have their height, weight, waist circumference, and hip circumference measured.
  arm group label: Single arm
  intervention type: Other
  intervention name: Questionnaires
  description: Participants will be asked to fill out questionnaires to collect information about their alcohol consumption, history of cigarette smoking, presence of diabetes, and history of liver disease and medications
  arm group label: Single arm
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Claude B Sirlin, MD
  role: Principal Investigator
  affiliation: University of California, San Diego
  last name: Yesenia Covarrubias
  phone: 8582462198
  email: ycovarrubias@health.ucsd.edu
  last name: Lael Ceriani
  phone: 8582462193
  email: lceriani@health.ucsd.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, San Diego
  investigator full name: Claude Sirlin
  investigator title: Professor of Radiology
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  sharing ipd: Yes
  ipd description: This is an SBIR study. De-identified coded data will be shared as per grant application.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: One year after completion
  ipd access criteria: Public
  ipd url: https://library.ucsd.edu/dc