<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/NCT02968680</url>
  </required_header>
  <id_info>
    <org_study_id>10M-15-3</org_study_id>
    <secondary_id>NCI-2016-01088</secondary_id>
    <secondary_id>10M-15-3</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02968680</nct_id>
  </id_info>
  <brief_title>Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma</brief_title>
  <official_title>Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting&#xD;
      sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that&#xD;
      may make it easier to see if the tumor cells have spread to the sentinel lymph node using an&#xD;
      ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound&#xD;
      contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.&#xD;
&#xD;
      II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC)&#xD;
      technique.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown&#xD;
      to be involved with metastatic disease.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also&#xD;
      undergo standard of care sentinel lymph node biopsy (SLNB).&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 24 and 48 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient accrual&#xD;
  </why_stopped>
  <start_date type="Actual">April 26, 2017</start_date>
  <completion_date type="Actual">January 9, 2020</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</primary_completion_date>
  <phase>Phase 1</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>Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Analyzed using descriptive comparison.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Cutaneous Melanoma</condition>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Diagnostic (sonazoid, ultrasound imaging, SLNB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sentinel Lymph Node Biopsy</intervention_name>
    <description>Undergo SLNB</description>
    <arm_group_label>Diagnostic (sonazoid, ultrasound imaging, SLNB)</arm_group_label>
    <other_name>Sentinel Node Biopsy</other_name>
    <other_name>Sentinel node biopsy alone</other_name>
    <other_name>SLNB</other_name>
    <other_name>SNB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasonography</intervention_name>
    <description>Undergo sonazoid-enhanced ultrasonography</description>
    <arm_group_label>Diagnostic (sonazoid, ultrasound imaging, SLNB)</arm_group_label>
    <other_name>ULTRASOUND</other_name>
    <other_name>Ultrasound Imaging</other_name>
    <other_name>Ultrasound Test</other_name>
    <other_name>Ultrasound, Medical</other_name>
    <other_name>US</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sonazoid</intervention_name>
    <description>Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.</description>
    <arm_group_label>Diagnostic (sonazoid, ultrasound imaging, SLNB)</arm_group_label>
    <other_name>Contrast ultrasound microvascular perfusion imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cutaneous melanoma with Breslow depth &gt; 1 mm or melanoma Breslow depth of 0.76 - 1.00&#xD;
             mm in setting of ulceration, extensive regression&#xD;
&#xD;
          -  Mitotic rate &gt;= 1/mm^2&#xD;
&#xD;
          -  Presence of angiolymphatic invasion&#xD;
&#xD;
          -  Deep positive margin&#xD;
&#xD;
          -  No known allergies to contrast material&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Patients with known cardiac shunt&#xD;
&#xD;
          -  Patients with class II heart failure or worse, per New York Heart Association (NYHA)&#xD;
             classification&#xD;
&#xD;
          -  Patients who have experienced an acute coronary syndrome or angina in the past 6&#xD;
             months&#xD;
&#xD;
          -  Patients who have undergone coronary artery bypass grafting (CABG) or coronary&#xD;
             stenting in the past 3 years&#xD;
&#xD;
          -  Patients with evidence of moderate or severe cardiac valvular disease on&#xD;
             echocardiogram&#xD;
&#xD;
          -  Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram&#xD;
&#xD;
          -  Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per&#xD;
             Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification&#xD;
&#xD;
          -  Patients with hypersensitivity to sonazoid or one of its components&#xD;
&#xD;
          -  Patients with hypersensitivity to egg or egg products, because sonazoid contains a&#xD;
             chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium)&#xD;
&#xD;
          -  Patients who cannot consent for themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin King, 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>March 2020</verification_date>
  <study_first_submitted>August 2, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</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>Melanoma</mesh_term>
    <mesh_term>Skin Neoplasms</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/NCT02968680
org study id: 10M-15-3
secondary id: NCI-2016-01088
secondary id: 10M-15-3
secondary id: P30CA014089
nct id: NCT02968680
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting
      sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that
      may make it easier to see if the tumor cells have spread to the sentinel lymph node using an
      ultrasound.
PRIMARY OBJECTIVES:

      I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound
      contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.

      II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC)
      technique.

      SECONDARY OBJECTIVES:

      I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown
      to be involved with metastatic disease.

      OUTLINE:

      Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also
      undergo standard of care sentinel lymph node biopsy (SLNB).

      After completion of study treatment, patients are followed up at 24 and 48 hours.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
time frame: Up to 1 year
description: Analyzed using descriptive comparison.
arm group label: Diagnostic (sonazoid, ultrasound imaging, SLNB)
arm group type: Experimental
description: Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.
intervention type: Procedure
intervention name: Sentinel Lymph Node Biopsy
description: Undergo SLNB
arm group label: Diagnostic (sonazoid, ultrasound imaging, SLNB)
other name: Sentinel Node Biopsy
other name: Sentinel node biopsy alone
other name: SLNB
other name: SNB
intervention type: Device
intervention name: Ultrasonography
description: Undergo sonazoid-enhanced ultrasonography
arm group label: Diagnostic (sonazoid, ultrasound imaging, SLNB)
other name: ULTRASOUND
other name: Ultrasound Imaging
other name: Ultrasound Test
other name: Ultrasound, Medical
other name: US
intervention type: Drug
intervention name: Sonazoid
description: Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.
arm group label: Diagnostic (sonazoid, ultrasound imaging, SLNB)
other name: Contrast ultrasound microvascular perfusion imaging
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin King, MD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Skin Neoplasms