<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/NCT03276845</url>
  </required_header>
  <id_info>
    <org_study_id>Multiparametric breast US</org_study_id>
    <nct_id>NCT03276845</nct_id>
  </id_info>
  <brief_title>Multiparametric High-resolution Ultrasound of the Breast</brief_title>
  <official_title>Multiparametric High-resolution 3-D Sonography With Color/Power-Doppler, Elastography and Contrast-enhanced Sonography for an Improved Detection and Characterization of Breast Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Despite advances in mammographic technique, mammography is limited in the detection and&#xD;
      diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades,&#xD;
      ultrasound has become an essential adjunct to mammography for the further characterization of&#xD;
      mammographically detected or palpable lesions or in the diagnosis of patients with dense&#xD;
      breasts.&#xD;
&#xD;
      However, in spite of defined morphological criteria for the differentiation of benign from&#xD;
      malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and&#xD;
      specificity. On the one hand, benign lesions may have one or more malignant characteristics&#xD;
      and thus require a biopsy. On the other hand, malignant lesions can also show benign&#xD;
      characteristics and thus make an accurate assessment difficult.&#xD;
&#xD;
      To overcome these limitations, newer sonographic methods have been developed. These include&#xD;
      elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.&#xD;
&#xD;
      The application of elastography is based on the fact that cancer has a higher stiffness than&#xD;
      healthy breast parenchyma.&#xD;
&#xD;
      In addition, cancers are characterized by neoangiogenesis and thus generally show an&#xD;
      increased vascularization in color and power Doppler. The detection of neoangiogenesis can be&#xD;
      improved by the application of contrast agents. The latter provides both morphological and&#xD;
      functional information about tumors, through the study of the contrast agent kinetics.&#xD;
&#xD;
      Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way,&#xD;
      the interaction between the tumor and the surrounding healthy tissue can be better&#xD;
      appreciated.&#xD;
&#xD;
      The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5)&#xD;
      breast lesions by using high-resolution sonography, including elastography, color/power&#xD;
      Doppler, contrast agent application and 3D sonography. Both morphological and functional&#xD;
      information can thus be obtained. The primary hypothesis of this study is that this&#xD;
      multiparametric approach will improve the detection and characterization of breast lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy (sensitivity, specificity, area under the receiver operating characteristic-ROC curve)</measure>
    <time_frame>2 years</time_frame>
    <description>H0: There is no difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.&#xD;
H1: There is a difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound of the breast</intervention_name>
    <description>Multiparametric ultrasound of the breast including elastography, color/power Doppler, contrast agent application and 3D sonography.</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical, mammographic, MR-tomographic and/or ultrasonographic verification of a&#xD;
             suspicious breast lesion (BIRADS 4 and 5)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Histopathological verification of the lesions either by core biopsy or by surgical&#xD;
             excision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable or non-compliant patients&#xD;
&#xD;
          -  Pregnant or lactating patients or patients with suspected pregnancy&#xD;
&#xD;
          -  Known contraindication to the intravenous administration of US contrast agents&#xD;
&#xD;
          -  Acute or chronic renal insufficiency&#xD;
&#xD;
          -  Pre- or post-transplant patients&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Panagiotis Kapetas</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Ultrasound</keyword>
  <keyword>Elastography</keyword>
  <keyword>Doppler Ultrasound</keyword>
  <keyword>Contrast enhanced Ultrasound</keyword>
  <keyword>Three-dimensional Ultrasound</keyword>
  <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>August 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03276845/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03276845
org study id: Multiparametric breast US
nct id: NCT03276845
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite advances in mammographic technique, mammography is limited in the detection and
      diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades,
      ultrasound has become an essential adjunct to mammography for the further characterization of
      mammographically detected or palpable lesions or in the diagnosis of patients with dense
      breasts.

      However, in spite of defined morphological criteria for the differentiation of benign from
      malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and
      specificity. On the one hand, benign lesions may have one or more malignant characteristics
      and thus require a biopsy. On the other hand, malignant lesions can also show benign
      characteristics and thus make an accurate assessment difficult.

      To overcome these limitations, newer sonographic methods have been developed. These include
      elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.

      The application of elastography is based on the fact that cancer has a higher stiffness than
      healthy breast parenchyma.

      In addition, cancers are characterized by neoangiogenesis and thus generally show an
      increased vascularization in color and power Doppler. The detection of neoangiogenesis can be
      improved by the application of contrast agents. The latter provides both morphological and
      functional information about tumors, through the study of the contrast agent kinetics.

      Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way,
      the interaction between the tumor and the surrounding healthy tissue can be better
      appreciated.

      The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5)
      breast lesions by using high-resolution sonography, including elastography, color/power
      Doppler, contrast agent application and 3D sonography. Both morphological and functional
      information can thus be obtained. The primary hypothesis of this study is that this
      multiparametric approach will improve the detection and characterization of breast lesions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
measure: Diagnostic accuracy (sensitivity, specificity, area under the receiver operating characteristic-ROC curve)
time frame: 2 years
description: H0: There is no difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.
H1: There is a difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.
arm group label: 1
arm group type: Other
intervention type: Diagnostic Test
intervention name: Ultrasound of the breast
description: Multiparametric ultrasound of the breast including elastography, color/power Doppler, contrast agent application and 3D sonography.
arm group label: 1
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Panagiotis Kapetas
investigator title: M.D.
provided document: 