<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/NCT02977247</url>
  </required_header>
  <id_info>
    <org_study_id>DMT-2015.001 ARM 2</org_study_id>
    <secondary_id>Protocol ID: 20151525</secondary_id>
    <nct_id>NCT02977247</nct_id>
  </id_info>
  <brief_title>Delphinus SoftVue Prospective Case Collection - ARM 2</brief_title>
  <acronym>SV PCC ARM2</acronym>
  <official_title>ARM 2: A Prospective, Multicenter, Multi-arm, Clinical Case Collection Program to Acquire Breast Image Data and Establish an Image Library of Exams for Use in Future Research Studies, Training, and Product Development Efforts.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Delphinus Medical Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Delphinus Medical Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear&#xD;
      ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and&#xD;
      K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of&#xD;
      transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a&#xD;
      replacement for screening mammography.&#xD;
&#xD;
      SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the&#xD;
      whole breast. While the patient lays prone on a padded table with one breast comfortably&#xD;
      submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the&#xD;
      breast and pulses low-frequency sound waves through the water and into the breast tissue.&#xD;
      More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive&#xD;
      ultrasound signals to analyze echoes from the breast anatomy in all directions, from the&#xD;
      chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound&#xD;
      waves off of tissue boundaries and structures within the breast, but because the transducer&#xD;
      surrounds the whole breast, SoftVue also captures signals that are transmitted through the&#xD;
      breast. This additional transmission data enhances the visualization of the anatomic&#xD;
      structure of the breast tissue and is not currently available in any other commercially&#xD;
      marketed breast ultrasound device.&#xD;
&#xD;
      This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved&#xD;
      and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki&#xD;
      and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000&#xD;
      women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly&#xD;
      limited to case collection and is non-interventional; any investigational and/or statistical&#xD;
      plans for future analyses will be prepared and registered separately, if they are applicable&#xD;
      to the requirements of FDAAA 801.&#xD;
&#xD;
      Arm 2 is limited to the cohort of diagnostic female patients of any breast density&#xD;
      composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after&#xD;
      diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic&#xD;
      imaging and SV exams, from the same patient, demographic information, and clinical outcome&#xD;
      data, will be collected during diagnostic workup. Ultrasound characteristics for all types of&#xD;
      lesions, whether they are benign or malignant, will be collected as well as objective and&#xD;
      subjective breast density composition data. Ultrasound image data may be acquired with&#xD;
      modified SoftVue devices, which have passed safety and quality evaluations per Delphinus'&#xD;
      quality management system (QMS) and satisfy design change control standards, at select&#xD;
      clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility,&#xD;
      validation, and verification testing for engineering and product development purposes.&#xD;
&#xD;
      The exams and clinical data accumulated in this prospective case collection (PCC) protocol&#xD;
      will populate a database from which future investigations may be designed for peer reviewed&#xD;
      publication, development of user training curricula, building teaching case, and creating new&#xD;
      marketing materials for SoftVue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MEDICAL DEVICES:&#xD;
&#xD;
        -  SoftVue™ (SV) automated whole breast ultrasound system, 510(k) Cleared for B-Mode&#xD;
           ultrasound breast imaging, manufactured by Delphinus Medical Technologies.&#xD;
&#xD;
        -  SoftVue™ with device modifications (software, hardware, user-interface), safety-tested&#xD;
           for human use to complete feasibility, verification, and validation testing as a routine&#xD;
           part of product development and performed in accordance with FDA 21 CFR 812.2 (b),&#xD;
           manufactured by Delphinus Medical Technologies.&#xD;
&#xD;
        -  Full-field digital mammography (FFDM), FDA Approved for breast screening and diagnosis,&#xD;
           various manufacturers. (If clinically indicated)&#xD;
&#xD;
        -  Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis,&#xD;
           various manufacturers.&#xD;
&#xD;
        -  Handheld Ultrasound (HHUS), FDA-Cleared for diagnostic breast imaging, various&#xD;
           manufacturers. (If clinically indicated)&#xD;
&#xD;
        -  Other diagnostic tests and medical device examinations of the breast, including, but not&#xD;
           limited to MRI, BSGI, PET, biopsy, and elastography, on the order of a licensed&#xD;
           physician, when clinically indicated.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
        -  Primary: To establish a library of cases for use in future SoftVue™ research studies,&#xD;
           user training, and marketing.&#xD;
&#xD;
        -  Secondary: Determine the frequency and severity of adverse events (AEs) to further&#xD;
           evaluate the safety of SoftVue.&#xD;
&#xD;
      ENDPOINTS:&#xD;
&#xD;
      From multiple clinical sites whichever comes first:&#xD;
&#xD;
      • Up to 1,000 total enrolled subjects&#xD;
&#xD;
      SITES:&#xD;
&#xD;
      At least six (≥ 6) qualified clinical sites in the United States&#xD;
&#xD;
        -  MQSA Certified&#xD;
&#xD;
        -  Digital Breast Tomosynthesis Screening Program Implemented&#xD;
&#xD;
        -  Academic, Community Hospital, or Private Practice Setting&#xD;
&#xD;
      PROJECT DESIGN AND PROCEDURES:&#xD;
&#xD;
        -  Potential participants will be recruited from the group of women presenting for&#xD;
           diagnostic evaluation or biopsy at multiple clinical sites.&#xD;
&#xD;
        -  All participants will complete the same standard care diagnostic evaluations that were&#xD;
           recommended by a physician&#xD;
&#xD;
        -  Eligible patients will receive a SV scan at the time of their scheduled diagnostic&#xD;
           appointments, preferably prior to biopsy&#xD;
&#xD;
        -  Investigators at the sites will compare SV images to the accompanying diagnostic images&#xD;
           and pathology results&#xD;
&#xD;
        -  No clinical SV interpretation will be performed and no clinical interventions will be&#xD;
           made or changed based on SV images&#xD;
&#xD;
        -  All evaluation results, diagnosis and treatment outcomes will be recorded&#xD;
&#xD;
        -  Cancer status for all participants will be surveyed from program entry until and&#xD;
           including the completion of physician recommended diagnostic workup&#xD;
&#xD;
        -  A case will be determined cancer negative if the participant has non-malignant breast&#xD;
           biopsy findings or confirmed non-suspicious diagnostic breast imaging findings&#xD;
&#xD;
        -  A case will be determined cancer positive if a pathological evaluation confirms a breast&#xD;
           cancer diagnosis (malignancy)&#xD;
&#xD;
      STATISTICAL ANALYSIS:&#xD;
&#xD;
        -  Demographic characteristics (age, race, and ethnicity) and other baseline&#xD;
           characteristics (e.g., project arm, project site, breast density, lesion-specific&#xD;
           characteristics) will be tabulated for all participants.&#xD;
&#xD;
        -  A flow diagram or table will illustrate patient disposition (&quot;accountability of patient&#xD;
           cohort&quot;) including reasons for ineligibility and/or unevaluability.&#xD;
&#xD;
        -  Safety will be summarized for all enrolled women. With the exception of anticipated&#xD;
           events, adverse events (AEs) and serious adverse events (SAEs), occurring from the time&#xD;
           of enrollment (SoftVue) and for 24 hours following the conclusion of the SoftVue exam,&#xD;
           will be recorded.&#xD;
&#xD;
        -  A separate statistical plan will be developed for any future analysis that includes&#xD;
           justification of sample size and, if applicable to the requirements of FDAAA 801, will&#xD;
           be registered separately in order to share the results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>No Breast Cancer</measure>
    <time_frame>Current Diagnostic Evaluation Episode, 0 to 60 Days</time_frame>
    <description>Non-Cancer cases, confirmed by normal or negative breast imaging findings or concordant breast biopsy with benign pathology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast Cancer</measure>
    <time_frame>Current Diagnostic Evaluation Episode, 0 to 60 Days</time_frame>
    <description>Cancer cases, confirmed by breast biopsy with malignant pathology</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1150</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Women undergoing routine diagnostic breast evaluation</arm_group_label>
    <description>Non-Interventional: Women presenting to enrollment sites for diagnostic examinations of symptoms or imaging findings, as recommended by a physician, and assigned BI-RADS category 4 or 5 (biopsy indicated).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Interventional</intervention_name>
    <description>Only standard care procedures will be performed for clinical intervention and diagnostic purposes.</description>
    <arm_group_label>Women undergoing routine diagnostic breast evaluation</arm_group_label>
    <other_name>Standard Medical Care</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automated Whole Breast Ultrasound</intervention_name>
    <description>Bilateral breast ultrasound images will be captured, but not clinically evaluated for diagnostic purposes by a physician.</description>
    <arm_group_label>Women undergoing routine diagnostic breast evaluation</arm_group_label>
    <other_name>SoftVue, AWBUS, ABUS, 3D Breast Ultrasound, 3D ABUS, 3D Ultrasound, 3D US</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Arm 2 is limited to the cohort of diagnostic women of any breast density composition&#xD;
        category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after diagnostic&#xD;
        imaging. Matched sets of diagnostic imaging with DBT* and SV exams from the same patient,&#xD;
        demographic information, and clinical outcome data, will be collected during diagnostic&#xD;
        workup. Ultrasound characteristics for all types of lesions, whether they are benign or&#xD;
        malignant, will be collected as well as objective and subjective breast density composition&#xD;
        data. Ultrasound image data may be acquired with modified SoftVue devices, which have&#xD;
        passed safety and quality evaluations per Delphinus' quality management system (QMS) and&#xD;
        satisfy design change control standards, at select clinical sites in accordance with 21 CFR&#xD;
        812.2 (b), as a routine part of feasibility, validation, and verification testing for&#xD;
        engineering and product development purposes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Any race or ethnicity&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Findings of concern on clinical breast exam or imaging&#xD;
&#xD;
          -  Scheduled for diagnostic imaging, needle biopsy, excisional biopsy, or&#xD;
             post-needle-biopsy visit&#xD;
&#xD;
          -  Diagnostic imaging assessment category BI-RADS 4 or 5 and willing to undergo&#xD;
             biopsy(ies) or, per the Principal Investigator, subject's case would be beneficial for&#xD;
             use in the lesion atlas or teaching library&#xD;
&#xD;
          -  Agrees to be contacted by site staff if a recommended biopsy is not completed within&#xD;
             the appropriate time frame&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Unwilling/unable to comply with the protocol and follow-up recommendations&#xD;
&#xD;
          -  Lumpectomy or excisional biopsy of the primary region of interest performed prior to&#xD;
             SoftVue imaging, such that there are not sufficient findings to make the case useful&#xD;
             for the lesion atlas or teaching library&#xD;
&#xD;
          -  Weight exceeds 350lbs&#xD;
&#xD;
          -  Currently pregnant or lactating by patient self-report&#xD;
&#xD;
          -  Weeping rash, open wounds, or unhealed sores on the breast&#xD;
&#xD;
          -  Bilateral mastectomy&#xD;
&#xD;
          -  Unable to lay prone on the scan table for up to 15 minutes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary W Yamashita, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keck School of Medicine, University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Keck School of Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SouthCoast Imaging</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Dearborn Breast Care Center</name>
      <address>
        <city>Dearborn</city>
        <state>Michigan</state>
        <zip>48124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Imaging Services</name>
      <address>
        <city>Washington</city>
        <state>Missouri</state>
        <zip>93090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elizabeth Wende Breast Care</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Breast Imaging Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weinstein Imaging Associates</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension St. Elizabeth, Radiology Associates of the Fox Valley</name>
      <address>
        <city>Appleton</city>
        <state>Wisconsin</state>
        <zip>54911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.delphinusmt.com/</url>
    <description>Delphinus Medical Technologies</description>
  </link>
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  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SoftVue</keyword>
  <keyword>Dense Breast Tissue</keyword>
  <keyword>Breast Screening</keyword>
  <keyword>Abnormal Breast</keyword>
  <keyword>Normal Breast</keyword>
  <keyword>Breast Imaging</keyword>
  <keyword>Breast Biopsy</keyword>
  <keyword>Mammography</keyword>
  <keyword>Tomosynthesis</keyword>
  <keyword>Automated Breast Ultrasound</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Breast Carcinoma</keyword>
  <keyword>Breast Tumors</keyword>
  <keyword>Mammary Carcinoma</keyword>
  <keyword>Malignant Breast Tumor</keyword>
  <keyword>Mammary Neoplasm</keyword>
  <keyword>Mammary Cancer</keyword>
  <keyword>ABUS</keyword>
  <keyword>AWBUS</keyword>
  <keyword>Breast Tomography</keyword>
  <keyword>ATUS</keyword>
  <keyword>ABTUS</keyword>
  <keyword>Mammogram</keyword>
  <keyword>3D Mammogram</keyword>
  <keyword>3D ABUS</keyword>
  <keyword>3D Breast Ultrasound</keyword>
  <keyword>DBT</keyword>
  <keyword>FFDM</keyword>
  <keyword>Digital Mammography</keyword>
  <keyword>Breast Ultrasound</keyword>
  <keyword>Dense Breasts</keyword>
  <keyword>Breast Density</keyword>
  <keyword>Dense Parenchyma</keyword>
  <keyword>Asymptomatic</keyword>
  <keyword>Delphinus</keyword>
  <keyword>Delphinus Medical Technologies</keyword>
  <keyword>Diagnostic Breast Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02977247
org study id: DMT-2015.001 ARM 2
secondary id: Protocol ID: 20151525
nct id: NCT02977247
lead sponsor: 
has dmc: No
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear
      ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and
      K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of
      transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a
      replacement for screening mammography.

      SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the
      whole breast. While the patient lays prone on a padded table with one breast comfortably
      submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the
      breast and pulses low-frequency sound waves through the water and into the breast tissue.
      More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive
      ultrasound signals to analyze echoes from the breast anatomy in all directions, from the
      chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound
      waves off of tissue boundaries and structures within the breast, but because the transducer
      surrounds the whole breast, SoftVue also captures signals that are transmitted through the
      breast. This additional transmission data enhances the visualization of the anatomic
      structure of the breast tissue and is not currently available in any other commercially
      marketed breast ultrasound device.

      This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved
      and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki
      and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000
      women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly
      limited to case collection and is non-interventional; any investigational and/or statistical
      plans for future analyses will be prepared and registered separately, if they are applicable
      to the requirements of FDAAA 801.

      Arm 2 is limited to the cohort of diagnostic female patients of any breast density
      composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after
      diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic
      imaging and SV exams, from the same patient, demographic information, and clinical outcome
      data, will be collected during diagnostic workup. Ultrasound characteristics for all types of
      lesions, whether they are benign or malignant, will be collected as well as objective and
      subjective breast density composition data. Ultrasound image data may be acquired with
      modified SoftVue devices, which have passed safety and quality evaluations per Delphinus'
      quality management system (QMS) and satisfy design change control standards, at select
      clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility,
      validation, and verification testing for engineering and product development purposes.

      The exams and clinical data accumulated in this prospective case collection (PCC) protocol
      will populate a database from which future investigations may be designed for peer reviewed
      publication, development of user training curricula, building teaching case, and creating new
      marketing materials for SoftVue.
MEDICAL DEVICES:

        -  SoftVue™ (SV) automated whole breast ultrasound system, 510(k) Cleared for B-Mode
           ultrasound breast imaging, manufactured by Delphinus Medical Technologies.

        -  SoftVue™ with device modifications (software, hardware, user-interface), safety-tested
           for human use to complete feasibility, verification, and validation testing as a routine
           part of product development and performed in accordance with FDA 21 CFR 812.2 (b),
           manufactured by Delphinus Medical Technologies.

        -  Full-field digital mammography (FFDM), FDA Approved for breast screening and diagnosis,
           various manufacturers. (If clinically indicated)

        -  Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis,
           various manufacturers.

        -  Handheld Ultrasound (HHUS), FDA-Cleared for diagnostic breast imaging, various
           manufacturers. (If clinically indicated)

        -  Other diagnostic tests and medical device examinations of the breast, including, but not
           limited to MRI, BSGI, PET, biopsy, and elastography, on the order of a licensed
           physician, when clinically indicated.

      OBJECTIVES:

        -  Primary: To establish a library of cases for use in future SoftVue™ research studies,
           user training, and marketing.

        -  Secondary: Determine the frequency and severity of adverse events (AEs) to further
           evaluate the safety of SoftVue.

      ENDPOINTS:

      From multiple clinical sites whichever comes first:

      • Up to 1,000 total enrolled subjects

      SITES:

      At least six (≥ 6) qualified clinical sites in the United States

        -  MQSA Certified

        -  Digital Breast Tomosynthesis Screening Program Implemented

        -  Academic, Community Hospital, or Private Practice Setting

      PROJECT DESIGN AND PROCEDURES:

        -  Potential participants will be recruited from the group of women presenting for
           diagnostic evaluation or biopsy at multiple clinical sites.

        -  All participants will complete the same standard care diagnostic evaluations that were
           recommended by a physician

        -  Eligible patients will receive a SV scan at the time of their scheduled diagnostic
           appointments, preferably prior to biopsy

        -  Investigators at the sites will compare SV images to the accompanying diagnostic images
           and pathology results

        -  No clinical SV interpretation will be performed and no clinical interventions will be
           made or changed based on SV images

        -  All evaluation results, diagnosis and treatment outcomes will be recorded

        -  Cancer status for all participants will be surveyed from program entry until and
           including the completion of physician recommended diagnostic workup

        -  A case will be determined cancer negative if the participant has non-malignant breast
           biopsy findings or confirmed non-suspicious diagnostic breast imaging findings

        -  A case will be determined cancer positive if a pathological evaluation confirms a breast
           cancer diagnosis (malignancy)

      STATISTICAL ANALYSIS:

        -  Demographic characteristics (age, race, and ethnicity) and other baseline
           characteristics (e.g., project arm, project site, breast density, lesion-specific
           characteristics) will be tabulated for all participants.

        -  A flow diagram or table will illustrate patient disposition ("accountability of patient
           cohort") including reasons for ineligibility and/or unevaluability.

        -  Safety will be summarized for all enrolled women. With the exception of anticipated
           events, adverse events (AEs) and serious adverse events (SAEs), occurring from the time
           of enrollment (SoftVue) and for 24 hours following the conclusion of the SoftVue exam,
           will be recorded.

        -  A separate statistical plan will be developed for any future analysis that includes
           justification of sample size and, if applicable to the requirements of FDAAA 801, will
           be registered separately in order to share the results.
observational model: Other
time perspective: Prospective
measure: No Breast Cancer
time frame: Current Diagnostic Evaluation Episode, 0 to 60 Days
description: Non-Cancer cases, confirmed by normal or negative breast imaging findings or concordant breast biopsy with benign pathology.
measure: Breast Cancer
time frame: Current Diagnostic Evaluation Episode, 0 to 60 Days
description: Cancer cases, confirmed by breast biopsy with malignant pathology
arm group label: Women undergoing routine diagnostic breast evaluation
description: Non-Interventional: Women presenting to enrollment sites for diagnostic examinations of symptoms or imaging findings, as recommended by a physician, and assigned BI-RADS category 4 or 5 (biopsy indicated).
intervention type: Other
intervention name: Non-Interventional
description: Only standard care procedures will be performed for clinical intervention and diagnostic purposes.
arm group label: Women undergoing routine diagnostic breast evaluation
other name: Standard Medical Care
intervention type: Device
intervention name: Automated Whole Breast Ultrasound
description: Bilateral breast ultrasound images will be captured, but not clinically evaluated for diagnostic purposes by a physician.
arm group label: Women undergoing routine diagnostic breast evaluation
other name: SoftVue, AWBUS, ABUS, 3D Breast Ultrasound, 3D ABUS, 3D Ultrasound, 3D US
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mary W Yamashita, MD
role: Principal Investigator
affiliation: Keck School of Medicine, University of Southern California
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.delphinusmt.com/
description: Delphinus Medical Technologies
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responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No