<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/NCT01698658</url>
  </required_header>
  <id_info>
    <org_study_id>2011-201</org_study_id>
    <secondary_id>NCI-2012-01745</secondary_id>
    <secondary_id>P30CA022453</secondary_id>
    <nct_id>NCT01698658</nct_id>
  </id_info>
  <brief_title>Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer</brief_title>
  <official_title>Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barbara Ann Karmanos Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Barbara Ann Karmanos Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with&#xD;
      breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may&#xD;
      help find and diagnose breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast&#xD;
      imaging.&#xD;
&#xD;
      II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard&#xD;
      ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and&#xD;
      construct reflection, sound speed and attenuation images with SoftVue.&#xD;
&#xD;
      III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal&#xD;
      landmark architecture) or masses previously identified with standard diagnostic evaluation&#xD;
      (palpation, mammography, standard US) using standard clock position and radial distance&#xD;
      measurements from the nipple.&#xD;
&#xD;
      IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance&#xD;
      imaging (MRI) findings from a subgroup of 50 patients.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the&#xD;
      breast.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 16, 2018</completion_date>
  <primary_completion_date type="Actual">November 16, 2018</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>Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution</measure>
    <time_frame>At time of procedure</time_frame>
    <description>For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ability of the system to identify pathological features previously identified by other imaging modalities</measure>
    <time_frame>At time of procedure</time_frame>
    <description>The sensitivity of the SoftVue system to identify pathologic features will be estimated with 95% confidence intervals using previous imaging studies as the gold standard.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Will be calculated along with 95% confidence intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sound speed as a percentage measure of dense breast tissue</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Compare measured sound speed values against known values for the range of tissue types imaged (e.g. fatty breasts should have average sound speeds consistent with known speeds for fatty tissue).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">657</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Diagnostic (SoftVue ultrasound tomography)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ultrasound tomography</intervention_name>
    <description>Undergo ultrasound tomography using SoftVue</description>
    <arm_group_label>Diagnostic (SoftVue ultrasound tomography)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>magnetic resonance imaging</intervention_name>
    <description>Undergo MRI of the breast</description>
    <arm_group_label>Diagnostic (SoftVue ultrasound tomography)</arm_group_label>
    <other_name>MRI</other_name>
    <other_name>NMR imaging</other_name>
    <other_name>NMRI</other_name>
    <other_name>nuclear magnetic resonance imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for mammogram, breast ultrasound and/or breast MRI&#xD;
&#xD;
          -  Breast size less than 22 cm diameter (ring diameter is 22cm)&#xD;
&#xD;
          -  Able to read or understand and provide informed consent&#xD;
&#xD;
          -  Weight &lt; 350lbs (patient bed max weight)&#xD;
&#xD;
          -  Non-pregnant and non-lactating&#xD;
&#xD;
          -  No open breast or chest wounds&#xD;
&#xD;
          -  No active skin infection&#xD;
&#xD;
          -  No serious medical or psychiatric illnesses that would prevent informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alit Amit-Yousif, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barbara Ann Karmanos Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Barbara Ann Karmanos Cancer Institute</investigator_affiliation>
    <investigator_full_name>Alit Amit-Yousif</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT01698658
org study id: 2011-201
secondary id: NCI-2012-01745
secondary id: P30CA022453
nct id: NCT01698658
lead sponsor: 
collaborator: 
has dmc: Yes
This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with
      breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may
      help find and diagnose breast cancer.
PRIMARY OBJECTIVES:

      I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast
      imaging.

      II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard
      ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and
      construct reflection, sound speed and attenuation images with SoftVue.

      III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal
      landmark architecture) or masses previously identified with standard diagnostic evaluation
      (palpation, mammography, standard US) using standard clock position and radial distance
      measurements from the nipple.

      IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance
      imaging (MRI) findings from a subgroup of 50 patients.

      OUTLINE:

      Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the
      breast.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution
time frame: At time of procedure
description: For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method.
measure: Ability of the system to identify pathological features previously identified by other imaging modalities
time frame: At time of procedure
description: The sensitivity of the SoftVue system to identify pathologic features will be estimated with 95% confidence intervals using previous imaging studies as the gold standard.
measure: Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)
time frame: At time of procedure
description: Will be calculated along with 95% confidence intervals.
measure: Sound speed as a percentage measure of dense breast tissue
time frame: At time of procedure
description: Compare measured sound speed values against known values for the range of tissue types imaged (e.g. fatty breasts should have average sound speeds consistent with known speeds for fatty tissue).
arm group label: Diagnostic (SoftVue ultrasound tomography)
arm group type: Experimental
description: Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
intervention type: Other
intervention name: ultrasound tomography
description: Undergo ultrasound tomography using SoftVue
arm group label: Diagnostic (SoftVue ultrasound tomography)
intervention type: Procedure
intervention name: magnetic resonance imaging
description: Undergo MRI of the breast
arm group label: Diagnostic (SoftVue ultrasound tomography)
other name: MRI
other name: NMR imaging
other name: NMRI
other name: nuclear magnetic resonance imaging
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Alit Amit-Yousif, M.D.
role: Principal Investigator
affiliation: Barbara Ann Karmanos Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Barbara Ann Karmanos Cancer Institute
investigator full name: Alit Amit-Yousif
investigator title: Principal Investigator
mesh term: Breast Neoplasms