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/NCT05987514</url>
    </required_header>
    <id_info>
      <org_study_id>4175</org_study_id>
      <nct_id>NCT05987514</nct_id>
    </id_info>
    <brief_title>Multimodal Ultrasound and Hepatocellular Response to Local Treatments</brief_title>
    <official_title>Role of Dynamic Contrast-Enhanced Ultrasound (D-CEUS) and Shear-wave Elastography (SWE) in Predicting Response to Locoregional Treatments and Disease Recurrence in Patients Affected by Hepatocellular Carcinoma (HCC)</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>
        Consecutive patients with HCC who should undergo to locoregional treatments (ablation or&#xD;
        trans-arterial chemoembolization) according to international guidelines will be enrolled.&#xD;
        atients will undergo CEUS and SWE before and after 24 hours from the procedure as per&#xD;
        clinical practice in our center. Subsequently, the patients will continue the normal&#xD;
        follow-up which includes control computed tomography/magnetic resonance one month after&#xD;
        treatment and subsequently every three months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary objective: To evaluate the correlation between pre-treatment ultrasound parameters&#xD;
        (D-CEUS and elastography) and one-month response to therapy evaluated with contrast-enhanced&#xD;
        computed tomography.&#xD;
  &#xD;
        Secondary objective: To identify quantitative ultrasound parameters able to predict overall&#xD;
        survival and disease-free survival.&#xD;
  &#xD;
        Study design: Prospective single-center study. Methods: 50 consecutive patients with HCC who&#xD;
        should undergo to locoregional treatments (ablation or trans-arterial chemoembolization)&#xD;
        according to international guidelines will be enrolled in the Unit of Internal Medicine and&#xD;
        Gastroenterology of the Policlinico Gemelli. After obtaining informed consent and identifying&#xD;
        the target lesion in B-mode ultrasound, patients will undergo CEUS and SWE before and after&#xD;
        24 hours from the procedure as per clinical practice in our center. Subsequently, the&#xD;
        patients will continue the normal follow-up which includes control computed&#xD;
        tomography/magnetic resonance one month after treatment and subsequently every three months.&#xD;
        In addition, the personal, clinical and laboratory data necessary to determine the&#xD;
        hepatological scores of disease severity such as MELD and Child-Pugh will be collected. The&#xD;
        study has an expected duration of one year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 7, 2021</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>predicting HCC response to treatment</measure>
      <time_frame>one month after local treatment</time_frame>
      <description>to quantify peak enhancement intensity in Arbitray Units AU(measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC, stratified according to one-month treatment response (responders or non-responders) assessed by computed tomography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>predicting HCC response to treatment</measure>
      <time_frame>one month after local treatment</time_frame>
      <description>to quantify mean HCC stiffness in patients undergoing local treatments for HCC, stratified according to one-month treatment response (responders or non-responders) assessed by computed tomography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>predicting overall survival</measure>
      <time_frame>12 months after treatment</time_frame>
      <description>to identify association between the peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC and time of survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>predicting disease-free survival</measure>
      <time_frame>12 months after treatment</time_frame>
      <description>to identify the association between the peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC and time of disease-free survival</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients affected by hepatocellular carcinoma needing to undergo loco-regional treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>multimodal ultrasound</intervention_name>
      <description>contrast-enhanced ultrasound and shear wave elastography on liver target lesion</description>
      <arm_group_label>Patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria adult patients with single nodule hepatocellular carcinoma detectable&#xD;
          with B-mode ultrasound and scheduled for locoregional treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  liver failure&#xD;
  &#xD;
            -  previous treatments fo hepatocellular carcinoma&#xD;
  &#xD;
            -  chronic or acute heart failure&#xD;
  &#xD;
            -  known ipersesitivity to ultrasound contrast agent&#xD;
  &#xD;
            -  pregnancy and 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_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 14, 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 14, 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>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</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/NCT05987514
  org study id: 4175
  nct id: NCT05987514
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Consecutive patients with HCC who should undergo to locoregional treatments (ablation or
        trans-arterial chemoembolization) according to international guidelines will be enrolled.
        atients will undergo CEUS and SWE before and after 24 hours from the procedure as per
        clinical practice in our center. Subsequently, the patients will continue the normal
        follow-up which includes control computed tomography/magnetic resonance one month after
        treatment and subsequently every three months.
  Primary objective: To evaluate the correlation between pre-treatment ultrasound parameters
        (D-CEUS and elastography) and one-month response to therapy evaluated with contrast-enhanced
        computed tomography.
  
        Secondary objective: To identify quantitative ultrasound parameters able to predict overall
        survival and disease-free survival.
  
        Study design: Prospective single-center study. Methods: 50 consecutive patients with HCC who
        should undergo to locoregional treatments (ablation or trans-arterial chemoembolization)
        according to international guidelines will be enrolled in the Unit of Internal Medicine and
        Gastroenterology of the Policlinico Gemelli. After obtaining informed consent and identifying
        the target lesion in B-mode ultrasound, patients will undergo CEUS and SWE before and after
        24 hours from the procedure as per clinical practice in our center. Subsequently, the
        patients will continue the normal follow-up which includes control computed
        tomography/magnetic resonance one month after treatment and subsequently every three months.
        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: predicting HCC response to treatment
  time frame: one month after local treatment
  description: to quantify peak enhancement intensity in Arbitray Units AU(measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC, stratified according to one-month treatment response (responders or non-responders) assessed by computed tomography
  measure: predicting HCC response to treatment
  time frame: one month after local treatment
  description: to quantify mean HCC stiffness in patients undergoing local treatments for HCC, stratified according to one-month treatment response (responders or non-responders) assessed by computed tomography
  measure: predicting overall survival
  time frame: 12 months after treatment
  description: to identify association between the peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC and time of survival
  measure: predicting disease-free survival
  time frame: 12 months after treatment
  description: to identify the association between the peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC and time of disease-free survival
  arm group label: Patients
  arm group type: Experimental
  description: Patients affected by hepatocellular carcinoma needing to undergo loco-regional treatment
  intervention type: Diagnostic Test
  intervention name: multimodal ultrasound
  description: contrast-enhanced ultrasound and shear wave elastography on liver target lesion
  arm group label: Patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  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: Carcinoma
  mesh term: Carcinoma, Hepatocellular