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/NCT05977764</url>
    </required_header>
    <id_info>
      <org_study_id>2824</org_study_id>
      <nct_id>NCT05977764</nct_id>
    </id_info>
    <brief_title>Multimodal Ultrasound and Focal Liver Lesions (FLLs)</brief_title>
    <official_title>Role of Contrast-enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) to Characterize Focal Liver Lesions (FLLs)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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>
        Background and aim: FLLs are common findings in abdominal ultrasound and differential&#xD;
        diagnosis between benign and malignant lesions is often challenging, especially in patients&#xD;
        with chronic liver diseases. The diagnostic role of CEUS has already been defined by&#xD;
        international guidelines when lesions show a typical pattern for hepatocellular carcinoma&#xD;
        whereas in case of non-typical contrast enhanced patterns radiologic imaging or liver biopsy&#xD;
        are still needed. However, these techniques are more invasive and expensive than ultrasound.&#xD;
        Therefore, the aim of this study is to identify D-CEUS and SWE quantitative parameters useful&#xD;
        for characterizing FLLs.&#xD;
  &#xD;
        Study design: Prospective, observational, single-center study Methods: 50 consecutive adult&#xD;
        patients with focal liver lesions detectable with B-mode ultrasound will be enrolled in the&#xD;
        Unit of Internal Medicine and Gastroenterology of the Policlinico Gemelli. Exclusion criteria&#xD;
        will be liver failure, hearth failure, previous locoregional or systemic treatments for FLLs&#xD;
        (e.g. ablation, chemoembolization, alcoholization, chemotherapy), known allergy to ultrasound&#xD;
        contrast agents. After obtaining informed consent and identifying the target lesion in B-mode&#xD;
        ultrasound, patients will undergo CEUS and SWE and, subsequently, to computed&#xD;
        tomography/magnetic resonance/biopsy according to international guidelines and current&#xD;
        clinical practice. The average, maximum, minimum and standard deviation value of lesion&#xD;
        elasticity in KPa will be calculated using SWE. Three consecutive SWE acquisitions will be&#xD;
        performed both for the lesion and for the liver parenchyma and the average value of the three&#xD;
        measurements will be considered. The CEUS will allow the construction of signal intensity&#xD;
        curves as a function of time in a specific area of interest drawn manually. From these curves&#xD;
        a series of quantitative parameters related to the flow and volume of blood will be&#xD;
        extrapolated and in particular: peak intensity, PI (in Arbitrary Units, AU); time to peak, TP&#xD;
        ( in seconds); area under the time curve, AUC (in AU); slope of the wash-in curve, Pw (in AU&#xD;
        per second); average transit time, MTT (in seconds). In addition, the personal, clinical and&#xD;
        laboratory data necessary to determine the hepatological scores of disease severity such as&#xD;
        MELD and Child-Pugh will be collected. The study has an expected duration of one year.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 13, 2020</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Actual">February 24, 2023</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>to identify D-CEUS quantitative parameters useful for characterizing FLLs.</measure>
      <time_frame>one month after liver biopsy</time_frame>
      <description>to quantify peak enhancement intensity, PI (in Arbitrary Units, AU), measured by analysing D-CEUS time-intensity curves, in patients with FLLs undergoing liver biopsy and stratified according to the histologic exam.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Liver Neoplasms</condition>
    <arm_group>
      <arm_group_label>lesion target</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CEUS on lesion target</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ultrasound</intervention_name>
      <description>Contrast enhanced ultrasound</description>
      <arm_group_label>lesion target</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  written informed consent&#xD;
  &#xD;
            -  adult patients (more than 18 years old)&#xD;
  &#xD;
            -  focal liver lesions detectable with B-mode ultrasound&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  liver failure,&#xD;
  &#xD;
            -  hearth failure,&#xD;
  &#xD;
            -  previous locoregional or systemic treatments for FLLs (e.g. ablation,&#xD;
               chemoembolization, alcoholization, chemotherapy),&#xD;
  &#xD;
            -  known allergy to ultrasound contrast agents&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  lactation&#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>Maria Assunta Zocco, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maria Assunta Zocco</last_name>
      <phone>00393470597805</phone>
      <email>mariaassunta.zocco@policlinicogemelli.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fondazione Policlinico Gemelli IRCCS</name>
        <address>
          <city>Roma</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>MARIA ASSUNTA ZOCCO, PhD</last_name>
        <phone>00393470597805</phone>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>Zocco Maria Assunta</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT05977764
  org study id: 2824
  nct id: NCT05977764
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Background and aim: FLLs are common findings in abdominal ultrasound and differential
        diagnosis between benign and malignant lesions is often challenging, especially in patients
        with chronic liver diseases. The diagnostic role of CEUS has already been defined by
        international guidelines when lesions show a typical pattern for hepatocellular carcinoma
        whereas in case of non-typical contrast enhanced patterns radiologic imaging or liver biopsy
        are still needed. However, these techniques are more invasive and expensive than ultrasound.
        Therefore, the aim of this study is to identify D-CEUS and SWE quantitative parameters useful
        for characterizing FLLs.
  
        Study design: Prospective, observational, single-center study Methods: 50 consecutive adult
        patients with focal liver lesions detectable with B-mode ultrasound will be enrolled in the
        Unit of Internal Medicine and Gastroenterology of the Policlinico Gemelli. Exclusion criteria
        will be liver failure, hearth failure, previous locoregional or systemic treatments for FLLs
        (e.g. ablation, chemoembolization, alcoholization, chemotherapy), known allergy to ultrasound
        contrast agents. After obtaining informed consent and identifying the target lesion in B-mode
        ultrasound, patients will undergo CEUS and SWE and, subsequently, to computed
        tomography/magnetic resonance/biopsy according to international guidelines and current
        clinical practice. The average, maximum, minimum and standard deviation value of lesion
        elasticity in KPa will be calculated using SWE. Three consecutive SWE acquisitions will be
        performed both for the lesion and for the liver parenchyma and the average value of the three
        measurements will be considered. The CEUS will allow the construction of signal intensity
        curves as a function of time in a specific area of interest drawn manually. From these curves
        a series of quantitative parameters related to the flow and volume of blood will be
        extrapolated and in particular: peak intensity, PI (in Arbitrary Units, AU); time to peak, TP
        ( in seconds); area under the time curve, AUC (in AU); slope of the wash-in curve, Pw (in AU
        per second); average transit time, MTT (in seconds). In addition, the personal, clinical and
        laboratory data necessary to determine the hepatological scores of disease severity such as
        MELD and Child-Pugh will be collected. The study has an expected duration of one year.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: to identify D-CEUS quantitative parameters useful for characterizing FLLs.
  time frame: one month after liver biopsy
  description: to quantify peak enhancement intensity, PI (in Arbitrary Units, AU), measured by analysing D-CEUS time-intensity curves, in patients with FLLs undergoing liver biopsy and stratified according to the histologic exam.
  arm group label: lesion target
  arm group type: Experimental
  description: CEUS on lesion target
  intervention type: Other
  intervention name: Ultrasound
  description: Contrast enhanced ultrasound
  arm group label: lesion target
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Maria Assunta Zocco, PhD
  role: Principal Investigator
  affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  last name: Maria Assunta Zocco
  phone: 00393470597805
  email: mariaassunta.zocco@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: Zocco Maria Assunta
  investigator title: Prof
  mesh term: Liver Neoplasms