<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/NCT03297112</url>
  </required_header>
  <id_info>
    <org_study_id>16F.394</org_study_id>
    <nct_id>NCT03297112</nct_id>
  </id_info>
  <brief_title>Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery</brief_title>
  <official_title>Subharmonic Contrast Ultrasound for Improved Characterization for Adnexal Masses-A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lantheus Medical Imaging</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Thomas Jefferson University</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well contrast-enhanced subharmonic ultrasound imaging&#xD;
      works in improving the characterization of adnexal masses in patients undergoing surgery.&#xD;
      Contrast-enhanced subharmonic ultrasound imaging uses high-frequency sound waves to produce&#xD;
      images of internal organs and when combined with an ultrasound agent such as perflutren lipid&#xD;
      microspheres, may help improve imaging and management of adnexal masses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To develop qualitative subharmonic imaging (SHI) or SHI-derived quantitative biomarkers.&#xD;
&#xD;
      II. To generate pilot data for a study to evaluate if they improve the characterization of&#xD;
      benign and malignant adnexal masses compared to standard ultrasound or contrast enhanced&#xD;
      magnetic resonance imaging (MRI) or the risk of malignancy index (RMI).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the SHI depiction of adnexal masses' neovascularity in humans to intra-tumoral&#xD;
      microvascular density (iMVD) obtained from CD31 an immunohistochemical marker of&#xD;
      angiogenesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">September 4, 2018</completion_date>
  <primary_completion_date type="Actual">September 4, 2018</primary_completion_date>
  <phase>Early 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>Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>Baseline scan to day of surgery</time_frame>
    <description>The techniques will be compared using an analysis of variance (ANOVA) method (i.e., baseline ultrasound imaging, SHI, or MRI) as the dependent variable and outcome as the independent variables. Diagnostic accuracy of lesion identification as &quot;no lesion seen&quot;, &quot;definitely benign&quot;, &quot;indeterminate&quot; or &quot;definitely malignant&quot; based on independent reads by experience radiologists for SHI with and without contrast vs contrast-enhanced MRI (quantitative analysis). For qualitative analysis, digital images from the SHI imaging were reviewed by the independent radiologists for interpretation. Diagnostic accuracy reported as percentage of lesions correctly identified through SHI as compared to ultrasound or MRI as the gold standard.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of SHI Characterization Compared to the Risk of Malignancy Index</measure>
    <time_frame>Baseline scan to day of surgery</time_frame>
    <description>The ability of SHI to accurately characterize lesions as benign from malignant masses as compared to other imaging (ultrasound or MRI) and pathology will be analyzed using logistic regression and receiver operating characteristic (ROC) analyses.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Adnexal Mass</condition>
  <arm_group>
    <arm_group_label>contrast-enhanced subharmonic ultrasound imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perflutren Lipid Microspheres</intervention_name>
    <description>Given IV</description>
    <arm_group_label>contrast-enhanced subharmonic ultrasound imaging</arm_group_label>
    <other_name>Definity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Contrast-Enhanced Subharmonic Ultrasound Imaging</intervention_name>
    <description>Undergo contrast-enhanced subharmonic ultrasound imaging</description>
    <arm_group_label>contrast-enhanced subharmonic ultrasound imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be diagnosed with an adnexal mass&#xD;
&#xD;
          -  Be scheduled for surgery to remove the adnexal mass&#xD;
&#xD;
          -  Be clinically stable&#xD;
&#xD;
          -  If a female of child-bearing potential, must have a negative pregnancy test&#xD;
&#xD;
          -  Be conscious and able to comply with study procedures&#xD;
&#xD;
          -  Have read and signed the Institutional Review Board (IRB)-approved informed consent&#xD;
             form for participating in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females who are pregnant or nursing&#xD;
&#xD;
          -  Patients who have received an investigational drug in the 30 days before study drug&#xD;
             administration, or will receive one within 72 hours (h) afterwards&#xD;
&#xD;
          -  Patients with known or suspected right-to-left, bi-directional, or transient&#xD;
             right-to-left cardiac shunts&#xD;
&#xD;
          -  Patients with pulmonary hypertension or unstable cardiopulmonary conditions&#xD;
&#xD;
          -  Patients currently on chemotherapy or with other primary cancers requiring systemic or&#xD;
             hepatic loco-regional treatment&#xD;
&#xD;
          -  Patients who are clinically unstable, patients who are seriously or terminally ill&#xD;
             with a life expectancy of less than 1 month, and patients whose clinical course are&#xD;
             unpredictable; for example:&#xD;
&#xD;
               -  Patients on life support or in a critical care unit&#xD;
&#xD;
               -  Patients with unstable occlusive disease (e.g., crescendo angina)&#xD;
&#xD;
               -  Patients with clinically unstable cardiac arrhythmias, such as recurrent&#xD;
                  ventricular tachycardia&#xD;
&#xD;
               -  Patients with uncontrolled congestive heart failure (New York Heart Association&#xD;
                  [NYHA] class IV)&#xD;
&#xD;
               -  Patients with recent cerebral hemorrhage&#xD;
&#xD;
               -  Patients who have undergone surgery within 24 hours prior to the study&#xD;
                  sonographic examination&#xD;
&#xD;
          -  Patients with a history of anaphylactic allergy to Definity, manifested by one or more&#xD;
             of the following symptoms: generalized urticaria, difficulty in breathing, swelling of&#xD;
             the mouth and throat, hypotension, or shock&#xD;
&#xD;
          -  Patients with congenital heart defects&#xD;
&#xD;
          -  Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli&#xD;
&#xD;
          -  Patients with respiratory distress syndrome&#xD;
&#xD;
          -  Patients with thrombosis within the splenic vein&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Flemming Forsberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sidney Kimmel Cancer Center at Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sidney Kimmel Cancer Center at Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <results_first_submitted>June 25, 2019</results_first_submitted>
  <results_first_submitted_qc>September 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2019</results_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03297112/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Contrast-enhanced Subharmonic Ultrasound Imaging</title>
          <description>Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.&#xD;
Perflutren Lipid Microspheres: Given IV&#xD;
Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Contrast-enhanced Subharmonic Ultrasound Imaging</title>
          <description>Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.&#xD;
Perflutren Lipid Microspheres: Given IV&#xD;
Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI)</title>
        <description>The techniques will be compared using an analysis of variance (ANOVA) method (i.e., baseline ultrasound imaging, SHI, or MRI) as the dependent variable and outcome as the independent variables. Diagnostic accuracy of lesion identification as &quot;no lesion seen&quot;, &quot;definitely benign&quot;, &quot;indeterminate&quot; or &quot;definitely malignant&quot; based on independent reads by experience radiologists for SHI with and without contrast vs contrast-enhanced MRI (quantitative analysis). For qualitative analysis, digital images from the SHI imaging were reviewed by the independent radiologists for interpretation. Diagnostic accuracy reported as percentage of lesions correctly identified through SHI as compared to ultrasound or MRI as the gold standard.</description>
        <time_frame>Baseline scan to day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Contrast-enhanced Subharmonic Ultrasound Imaging</title>
            <description>Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.&#xD;
Perflutren Lipid Microspheres: Given IV&#xD;
Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging</description>
          </group>
        </group_list>
        <measure>
          <title>Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI)</title>
          <description>The techniques will be compared using an analysis of variance (ANOVA) method (i.e., baseline ultrasound imaging, SHI, or MRI) as the dependent variable and outcome as the independent variables. Diagnostic accuracy of lesion identification as &quot;no lesion seen&quot;, &quot;definitely benign&quot;, &quot;indeterminate&quot; or &quot;definitely malignant&quot; based on independent reads by experience radiologists for SHI with and without contrast vs contrast-enhanced MRI (quantitative analysis). For qualitative analysis, digital images from the SHI imaging were reviewed by the independent radiologists for interpretation. Diagnostic accuracy reported as percentage of lesions correctly identified through SHI as compared to ultrasound or MRI as the gold standard.</description>
          <units>percent accurate lesion identification</units>
          <param>Number</param>
          <units_analyzed>lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Qualitative analysis of CEUS SHI with contrast</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Qualitative analysis of CEUS SHI without contrast</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Accuracy of SHI Characterization Compared to the Risk of Malignancy Index</title>
        <description>The ability of SHI to accurately characterize lesions as benign from malignant masses as compared to other imaging (ultrasound or MRI) and pathology will be analyzed using logistic regression and receiver operating characteristic (ROC) analyses.</description>
        <time_frame>Baseline scan to day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Contrast-enhanced Subharmonic Ultrasound Imaging</title>
            <description>Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.&#xD;
Perflutren Lipid Microspheres: Given IV&#xD;
Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of SHI Characterization Compared to the Risk of Malignancy Index</title>
          <description>The ability of SHI to accurately characterize lesions as benign from malignant masses as compared to other imaging (ultrasound or MRI) and pathology will be analyzed using logistic regression and receiver operating characteristic (ROC) analyses.</description>
          <units>percent accurate m lesion identification</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 minutes after the second Definity injection</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Contrast-enhanced Subharmonic Ultrasound Imaging</title>
          <description>Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.&#xD;
Perflutren Lipid Microspheres: Given IV&#xD;
Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Flemming Forsberg, PhD</name_or_title>
      <organization>Sidney Kimmel Cancer Center at Thomas Jefferson University</organization>
      <phone>215-955-4870</phone>
      <email>flemming.forsberg@jefferson.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03297112
org study id: 16F.394
nct id: NCT03297112
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This pilot clinical trial studies how well contrast-enhanced subharmonic ultrasound imaging
      works in improving the characterization of adnexal masses in patients undergoing surgery.
      Contrast-enhanced subharmonic ultrasound imaging uses high-frequency sound waves to produce
      images of internal organs and when combined with an ultrasound agent such as perflutren lipid
      microspheres, may help improve imaging and management of adnexal masses.
PRIMARY OBJECTIVES:

      I. To develop qualitative subharmonic imaging (SHI) or SHI-derived quantitative biomarkers.

      II. To generate pilot data for a study to evaluate if they improve the characterization of
      benign and malignant adnexal masses compared to standard ultrasound or contrast enhanced
      magnetic resonance imaging (MRI) or the risk of malignancy index (RMI).

      SECONDARY OBJECTIVES:

      I. To compare the SHI depiction of adnexal masses' neovascularity in humans to intra-tumoral
      microvascular density (iMVD) obtained from CD31 an immunohistochemical marker of
      angiogenesis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI)
time frame: Baseline scan to day of surgery
description: The techniques will be compared using an analysis of variance (ANOVA) method (i.e., baseline ultrasound imaging, SHI, or MRI) as the dependent variable and outcome as the independent variables. Diagnostic accuracy of lesion identification as "no lesion seen", "definitely benign", "indeterminate" or "definitely malignant" based on independent reads by experience radiologists for SHI with and without contrast vs contrast-enhanced MRI (quantitative analysis). For qualitative analysis, digital images from the SHI imaging were reviewed by the independent radiologists for interpretation. Diagnostic accuracy reported as percentage of lesions correctly identified through SHI as compared to ultrasound or MRI as the gold standard.
measure: Accuracy of SHI Characterization Compared to the Risk of Malignancy Index
time frame: Baseline scan to day of surgery
description: The ability of SHI to accurately characterize lesions as benign from malignant masses as compared to other imaging (ultrasound or MRI) and pathology will be analyzed using logistic regression and receiver operating characteristic (ROC) analyses.
arm group label: contrast-enhanced subharmonic ultrasound imaging
arm group type: Experimental
description: Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.
intervention type: Drug
intervention name: Perflutren Lipid Microspheres
description: Given IV
arm group label: contrast-enhanced subharmonic ultrasound imaging
other name: Definity
intervention type: Procedure
intervention name: Contrast-Enhanced Subharmonic Ultrasound Imaging
description: Undergo contrast-enhanced subharmonic ultrasound imaging
arm group label: contrast-enhanced subharmonic ultrasound imaging
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Flemming Forsberg, PhD
role: Principal Investigator
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 