<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/NCT03300401</url>
  </required_header>
  <id_info>
    <org_study_id>3L-17-3</org_study_id>
    <secondary_id>NCI-2017-01422</secondary_id>
    <secondary_id>3L-17-3</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT03300401</nct_id>
  </id_info>
  <brief_title>Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization</brief_title>
  <official_title>The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing&#xD;
      patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced&#xD;
      ultrasound may provide detailed imaging of the tumor arteries after the injection of a&#xD;
      contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit&#xD;
      in the tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Investigate the relationship between hepatocellular carcinoma (HCC) tumor perfusion on&#xD;
      pre-procedural contrast-enhanced ultrasound (CEUS) time intensity curve (TIC) and&#xD;
      post-procedural Yttrium-90 (90Y) microsphere distribution after 90Y radioembolization (RE).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Study the potential of serial CEUS TIC examinations as a marker of tumor treatment&#xD;
      response as assessed at 20 - 24 week computed tomography (CT) follow-up.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at&#xD;
      baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo positron emission&#xD;
      tomography/computed tomography (PET/CT) after standard of care 90Y radioembolization at&#xD;
      baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Accrual issue&#xD;
  </why_stopped>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Anticipated">November 7, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 7, 2019</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>Local tumor response to therapy</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Diagnostic (CEUS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perflutren Lipid Microspheres</intervention_name>
    <description>Receive intravenous injection just prior to ultrasound</description>
    <arm_group_label>Diagnostic (CEUS)</arm_group_label>
    <other_name>Definity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulfur Hexafluoride Lipid Microspheres</intervention_name>
    <description>Receive intravenous injection just prior to ultrasound</description>
    <arm_group_label>Diagnostic (CEUS)</arm_group_label>
    <other_name>Lumason</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamic Contrast-Enhanced Ultrasound Imaging</intervention_name>
    <description>Undergo Contrast-Enhanced Ultrasound Imaging</description>
    <arm_group_label>Diagnostic (CEUS)</arm_group_label>
    <other_name>Contrast-Enhanced Ultrasound Imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET/CT</description>
    <arm_group_label>Diagnostic (CEUS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo CT scan</description>
    <arm_group_label>Diagnostic (CEUS)</arm_group_label>
    <other_name>Computerized Axial Tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Yttrium-90 (90Y)</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (CEUS)</arm_group_label>
    <other_name>90Y microsphere</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for 90Y radioembolization for HCC as part of their standard of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have already received tumor treatment (either systemic or loco-regional&#xD;
             such as previous Y90RE, microwave or radiofrequency [RF] ablation or transarterial&#xD;
             chemoembolization [TACE])&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Known cardiac shunt&#xD;
&#xD;
          -  Known pulmonary hypertension&#xD;
&#xD;
          -  History of hypersensitivity to Definity (perflutren lipid microsphere) or Lumason&#xD;
&#xD;
          -  History of hypersensitivity to iodinated contrast agent&#xD;
&#xD;
          -  Cannot consent for himself or herself&#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>Harshawn Malhi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC/Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>May 14, 2019</last_update_submitted>
  <last_update_submitted_qc>May 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Undecided</sharing_ipd>
  </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/NCT03300401
org study id: 3L-17-3
secondary id: NCI-2017-01422
secondary id: 3L-17-3
secondary id: P30CA014089
nct id: NCT03300401
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing
      patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced
      ultrasound may provide detailed imaging of the tumor arteries after the injection of a
      contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit
      in the tumor.
PRIMARY OBJECTIVES:

      I. Investigate the relationship between hepatocellular carcinoma (HCC) tumor perfusion on
      pre-procedural contrast-enhanced ultrasound (CEUS) time intensity curve (TIC) and
      post-procedural Yttrium-90 (90Y) microsphere distribution after 90Y radioembolization (RE).

      SECONDARY OBJECTIVES:

      I. Study the potential of serial CEUS TIC examinations as a marker of tumor treatment
      response as assessed at 20 - 24 week computed tomography (CT) follow-up.

      OUTLINE:

      Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at
      baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo positron emission
      tomography/computed tomography (PET/CT) after standard of care 90Y radioembolization at
      baseline.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Local tumor response to therapy
time frame: Up to 24 weeks
description: Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.
arm group label: Diagnostic (CEUS)
arm group type: Experimental
description: Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.
intervention type: Drug
intervention name: Perflutren Lipid Microspheres
description: Receive intravenous injection just prior to ultrasound
arm group label: Diagnostic (CEUS)
other name: Definity
intervention type: Drug
intervention name: Sulfur Hexafluoride Lipid Microspheres
description: Receive intravenous injection just prior to ultrasound
arm group label: Diagnostic (CEUS)
other name: Lumason
intervention type: Device
intervention name: Dynamic Contrast-Enhanced Ultrasound Imaging
description: Undergo Contrast-Enhanced Ultrasound Imaging
arm group label: Diagnostic (CEUS)
other name: Contrast-Enhanced Ultrasound Imaging
intervention type: Device
intervention name: Positron Emission Tomography
description: Undergo PET/CT
arm group label: Diagnostic (CEUS)
intervention type: Device
intervention name: Computed Tomography
description: Undergo CT scan
arm group label: Diagnostic (CEUS)
other name: Computerized Axial Tomography
intervention type: Biological
intervention name: Yttrium-90 (90Y)
description: Given IV
arm group label: Diagnostic (CEUS)
other name: 90Y microsphere
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harshawn Malhi, MD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided