<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/NCT04480437</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01-mp-BUS</org_study_id>
    <nct_id>NCT04480437</nct_id>
  </id_info>
  <brief_title>Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer</brief_title>
  <acronym>mp-BUS</acronym>
  <official_title>Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kantonsspital Baden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Federal Institute of Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is studied whether multi-parametric biomarkers such as speed-of-sound imaging or others,&#xD;
      applied during breast ultrasound (BUS) imaging allows to classify lesions according to its&#xD;
      malignancy. The standard reference intervention is BUS guided biopsy or the consensus of the&#xD;
      board of experts judging the BUS imaging results if no biopsy is done.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with a palpable lump in the breast or suspicious findings in X-ray mammography&#xD;
      typically undergo breast ultrasound examination as a supplemental imaging modality. Findings&#xD;
      are then used for tumour classification according the American Collage of Radiology (ACR)&#xD;
      Breast Imaging Reporting and Database System (BI-RADS) lexicon. Suspicious findings then&#xD;
      undergo ultrasound-guided biopsy, which causes discomfort for the patient and introduces high&#xD;
      emotional stress, and may involve - albeit very-small - risk of complications (such as&#xD;
      bleeding and infections).&#xD;
&#xD;
      Today conventional breast ultrasound B-mode images do not have the specificity to reliably&#xD;
      differentiate malignant and benign tissues in all cases and hence a biopsy intervention or&#xD;
      close follow-up is necessitated. Multiparametric imaging bio-markers such as the novel method&#xD;
      of speed-of-sound imaging may provide additional indicators to help to better classify&#xD;
      lesions prior to biopsy and avoid any further work-up.&#xD;
&#xD;
      The study collects data with an ultrasound device during normal BUS examination which is then&#xD;
      retrospectively processed to extract the desired multi-parametric BUS (mp-BUS) information of&#xD;
      imaged tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2020</start_date>
  <completion_date type="Actual">December 13, 2021</completion_date>
  <primary_completion_date type="Actual">December 13, 2021</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>
    <intervention_model_description>The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speed-of-sound imaging shows malignancy of lesion</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the non-inferiority or superiority of the multi-parametric method compared to the standard ultrasound technique, using BUS guided biopsy as gold standard, to determine the malignancy of a lesion in woman breast.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Study Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mp-BUS data collection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mp-BUS data collection</intervention_name>
    <description>Collect ultrasound raw data and B-mode images of all kind of breast lesions to external storage device.</description>
    <arm_group_label>Study Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who are suspected or suspected of having breast cancer and who are advised to&#xD;
             perform a detailed breast ultrasound or tissue sampling (biopsy)&#xD;
&#xD;
          -  Classification into groups:&#xD;
&#xD;
               -  Group 1: Foreseen for BUS guided biopsy&#xD;
&#xD;
               -  Group 2: BI-RADS classification I, II and III and foreseen for BUS only based&#xD;
                  diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lactating women&#xD;
&#xD;
          -  Women with mastitis&#xD;
&#xD;
          -  Vulnerable persons&#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>Kubik Rahel, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kantonsspital Baden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonsspital Baden</name>
      <address>
        <city>Baden</city>
        <zip>5404</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>December 27, 2021</last_update_submitted>
  <last_update_submitted_qc>December 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2021</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>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/NCT04480437
org study id: 2020-01-mp-BUS
nct id: NCT04480437
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is studied whether multi-parametric biomarkers such as speed-of-sound imaging or others,
      applied during breast ultrasound (BUS) imaging allows to classify lesions according to its
      malignancy. The standard reference intervention is BUS guided biopsy or the consensus of the
      board of experts judging the BUS imaging results if no biopsy is done.
Patients with a palpable lump in the breast or suspicious findings in X-ray mammography
      typically undergo breast ultrasound examination as a supplemental imaging modality. Findings
      are then used for tumour classification according the American Collage of Radiology (ACR)
      Breast Imaging Reporting and Database System (BI-RADS) lexicon. Suspicious findings then
      undergo ultrasound-guided biopsy, which causes discomfort for the patient and introduces high
      emotional stress, and may involve - albeit very-small - risk of complications (such as
      bleeding and infections).

      Today conventional breast ultrasound B-mode images do not have the specificity to reliably
      differentiate malignant and benign tissues in all cases and hence a biopsy intervention or
      close follow-up is necessitated. Multiparametric imaging bio-markers such as the novel method
      of speed-of-sound imaging may provide additional indicators to help to better classify
      lesions prior to biopsy and avoid any further work-up.

      The study collects data with an ultrasound device during normal BUS examination which is then
      retrospectively processed to extract the desired multi-parametric BUS (mp-BUS) information of
      imaged tissue.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Speed-of-sound imaging shows malignancy of lesion
time frame: 6 months
description: Evaluate the non-inferiority or superiority of the multi-parametric method compared to the standard ultrasound technique, using BUS guided biopsy as gold standard, to determine the malignancy of a lesion in woman breast.
arm group label: Study Intervention
arm group type: Experimental
description: mp-BUS data collection
intervention type: Device
intervention name: mp-BUS data collection
description: Collect ultrasound raw data and B-mode images of all kind of breast lesions to external storage device.
arm group label: Study Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kubik Rahel, Prof. Dr.
role: Principal Investigator
affiliation: Kantonsspital Baden
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No