<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/NCT03031561</url>
  </required_header>
  <id_info>
    <org_study_id>12D.17</org_study_id>
    <nct_id>NCT03031561</nct_id>
  </id_info>
  <brief_title>Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality</brief_title>
  <official_title>Breast Microcalcifications Identified With MicroPure as a Marker for Malignancy Compared to Grayscale Ultrasound and Mammography (Using Biopsy as the Reference Standard)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</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>
      This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting&#xD;
      breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound&#xD;
      sends sound waves into the body, and the sound waves reflected back are interpreted by the&#xD;
      machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives&#xD;
      color to the ultrasound images, which may allow doctors to better identify&#xD;
      microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that&#xD;
      cannot be felt but can be detected by imaging. A group of microcalcifications may indicate&#xD;
      that cancer is present.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of&#xD;
      microcalcifications with mammography as the reference standard.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the&#xD;
      characterization of breast abnormalities associated with microcalcifications using biopsy&#xD;
      results as the reference standard (sensitivity and specificity will be calculated).&#xD;
&#xD;
      II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast&#xD;
      microcalcifications with pathology as the reference standard.&#xD;
&#xD;
      III. Estimate the improvements in patient care that may be achievable if MicroPure guided&#xD;
      core needle biopsy procedures can replace some surgical excisions for the evaluation of&#xD;
      breast abnormalities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2012</start_date>
  <completion_date type="Actual">March 10, 2016</completion_date>
  <primary_completion_date type="Actual">April 30, 2015</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of microcalcifications seen on MicroPure ultrasound</measure>
    <time_frame>Baseline</time_frame>
    <description>The number of microcalcifications seen on MicroPure ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of microcalcifications seen on grayscale ultrasound</measure>
    <time_frame>Baseline</time_frame>
    <description>The number of microcalcifications seen on grayscale ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of microcalcifications determined by pathology findings</measure>
    <time_frame>Baseline</time_frame>
    <description>The results of the three imaging methods will be compared to the pathology findings using the American College of Radiology Breast Imaging Reporting and Data System lexicon for the assessment of breast lesions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Microcalcification</condition>
  <arm_group>
    <arm_group_label>Diagnostic (standard ultrasound, MicroPure, biopsy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Undergo standard ultrasound</description>
    <arm_group_label>Diagnostic (standard ultrasound, MicroPure, biopsy)</arm_group_label>
    <other_name>Ultrasound Imaging</other_name>
    <other_name>US</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MicoPure ultrasound</intervention_name>
    <description>Undergo MicoPure ultrasound</description>
    <arm_group_label>Diagnostic (standard ultrasound, MicroPure, biopsy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy of Breast</intervention_name>
    <description>Undergo breast biopsy or surgical resection</description>
    <arm_group_label>Diagnostic (standard ultrasound, MicroPure, biopsy)</arm_group_label>
    <other_name>Breast Biopsy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Give written informed consent&#xD;
&#xD;
          -  Be scheduled for a sonographic or stereotactic guided core needle biopsy or surgical&#xD;
             excision for the evaluation of a breast lesion or abnormality containing&#xD;
             microcalcifications seen on mammography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is clinically unstable, severely ill, or moribund&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 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>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>November 13, 2017</last_update_submitted>
  <last_update_submitted_qc>November 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</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>
    <mesh_term>Calcinosis</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/NCT03031561
org study id: 12D.17
nct id: NCT03031561
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting
      breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound
      sends sound waves into the body, and the sound waves reflected back are interpreted by the
      machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives
      color to the ultrasound images, which may allow doctors to better identify
      microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that
      cannot be felt but can be detected by imaging. A group of microcalcifications may indicate
      that cancer is present.
PRIMARY OBJECTIVES:

      I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of
      microcalcifications with mammography as the reference standard.

      SECONDARY OBJECTIVES:

      I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the
      characterization of breast abnormalities associated with microcalcifications using biopsy
      results as the reference standard (sensitivity and specificity will be calculated).

      II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast
      microcalcifications with pathology as the reference standard.

      III. Estimate the improvements in patient care that may be achievable if MicroPure guided
      core needle biopsy procedures can replace some surgical excisions for the evaluation of
      breast abnormalities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of microcalcifications seen on MicroPure ultrasound
time frame: Baseline
description: The number of microcalcifications seen on MicroPure ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.
measure: Number of microcalcifications seen on grayscale ultrasound
time frame: Baseline
description: The number of microcalcifications seen on grayscale ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.
measure: Number of microcalcifications determined by pathology findings
time frame: Baseline
description: The results of the three imaging methods will be compared to the pathology findings using the American College of Radiology Breast Imaging Reporting and Data System lexicon for the assessment of breast lesions.
arm group label: Diagnostic (standard ultrasound, MicroPure, biopsy)
arm group type: Experimental
description: Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.
intervention type: Device
intervention name: Ultrasound
description: Undergo standard ultrasound
arm group label: Diagnostic (standard ultrasound, MicroPure, biopsy)
other name: Ultrasound Imaging
other name: US
intervention type: Device
intervention name: MicoPure ultrasound
description: Undergo MicoPure ultrasound
arm group label: Diagnostic (standard ultrasound, MicroPure, biopsy)
intervention type: Procedure
intervention name: Biopsy of Breast
description: Undergo breast biopsy or surgical resection
arm group label: Diagnostic (standard ultrasound, MicroPure, biopsy)
other name: Breast Biopsy
criteria: 
gender: Female
gender based: Yes
minimum age: 18 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
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Calcinosis