<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/NCT02209129</url>
  </required_header>
  <id_info>
    <org_study_id>B322201421047</org_study_id>
    <nct_id>NCT02209129</nct_id>
  </id_info>
  <brief_title>Digital 3D Breast Tomosynthesis Versus 2D in Clinical Evaluation of High Risk Women</brief_title>
  <official_title>3D Digital Breast Tumorsynthesis Versus 2D Digital Mammography in the Clinical Evaluation of Women at High Risk for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with a higher breast cancer risk (higher than 17% according to the IBIS calculation)&#xD;
      will receive a 2D digital mammography together with a 3D tomosynthesis (so called combo tomo)&#xD;
      of both breasts in two views in order to investigate the additional value of tomosynthesis in&#xD;
      the diagnosis of breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor dectection rate</measure>
    <time_frame>2 years</time_frame>
    <description>The addititional value of 3D tomosythesis to 2D digital mammography will be evaluated by the cancer detection rate, falls negative and falls positive results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Falls negative, Falls positive results, accuracy</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>women at high risk for breast cancer</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        women with an increased risk for breast cancer &gt; 17% according to the IBIS calculation, and&#xD;
        also defined by the Multidisciplinary Breast centre UZ Leuven, Belgium&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women&#xD;
&#xD;
          -  more than 17% risk for breast cancer (IBIS calculation)&#xD;
&#xD;
          -  &gt; 40y old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 40y old&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chantal Van Ongeval, MD,Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chantal Van Ongeval, MD, Phd</last_name>
    <phone>+32 16 34 37 80</phone>
    <email>chantal.vanongeval@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hilde Vandenhoutte</last_name>
    <email>hilde.vandenhoutte@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZLeuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chantal Van Ongeval</last_name>
      <phone>+3216343780</phone>
      <email>chantal.vanongeval@uzleuven.be</email>
    </contact>
    <investigator>
      <last_name>Chantal Van Ongeval, MD,Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Chantal Van Ongeval, MD, Phd</investigator_full_name>
    <investigator_title>Prof. dr. Van Ongeval Chantal</investigator_title>
  </responsible_party>
  <keyword>digital breast tomosynthesis</keyword>
  <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/NCT02209129
org study id: B322201421047
nct id: NCT02209129
lead sponsor: 
has dmc: No
Patients with a higher breast cancer risk (higher than 17% according to the IBIS calculation)
      will receive a 2D digital mammography together with a 3D tomosynthesis (so called combo tomo)
      of both breasts in two views in order to investigate the additional value of tomosynthesis in
      the diagnosis of breast cancer.
observational model: Cohort
time perspective: Prospective
measure: Tumor dectection rate
time frame: 2 years
description: The addititional value of 3D tomosythesis to 2D digital mammography will be evaluated by the cancer detection rate, falls negative and falls positive results.
measure: Falls negative, Falls positive results, accuracy
time frame: 4 years
arm group label: women at high risk for breast cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Chantal Van Ongeval, MD,Phd
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
last name: Chantal Van Ongeval, MD, Phd
phone: +32 16 34 37 80
email: chantal.vanongeval@uzleuven.be
last name: Hilde Vandenhoutte
email: hilde.vandenhoutte@uzleuven.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Chantal Van Ongeval, MD, Phd
investigator title: Prof. dr. Van Ongeval Chantal
mesh term: Breast Neoplasms