<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/NCT01684735</url>
  </required_header>
  <id_info>
    <org_study_id>B322201213618</org_study_id>
    <nct_id>NCT01684735</nct_id>
  </id_info>
  <brief_title>Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation</brief_title>
  <official_title>Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation</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>
      Evaluation of the response to chemotherapy in breast cancer patients by the use of&#xD;
      Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy,&#xD;
      after one and 3 cycles of therapy and at the end of the therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Response to chemotherapy</measure>
    <time_frame>1 year</time_frame>
    <description>outcome is the results of pathology after chemotherapy and surgery. Data will be collected for a period of 1 year.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>women with BRCA and chemotherapy</arm_group_label>
    <description>women recently diagnosed with breast cancer and start with neo-adjuvant chemotherapy (6 cycles) before surgery/therapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        women diagnosed with breast cancer and treated with neo-adjuvant chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  core biopsy with diagnosis of breast cancer&#xD;
&#xD;
          -  start of neo-adjuvant chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  magnetic resonance imaging incompatibility&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>May 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diffusion-weighted magnetic resonance imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</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/NCT01684735
org study id: B322201213618
nct id: NCT01684735
lead sponsor: 
has dmc: No
Evaluation of the response to chemotherapy in breast cancer patients by the use of
      Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy,
      after one and 3 cycles of therapy and at the end of the therapy.
observational model: Cohort
time perspective: Prospective
measure: Response to chemotherapy
time frame: 1 year
description: outcome is the results of pathology after chemotherapy and surgery. Data will be collected for a period of 1 year.
arm group label: women with BRCA and chemotherapy
description: women recently diagnosed with breast cancer and start with neo-adjuvant chemotherapy (6 cycles) before surgery/therapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Chantal Van Ongeval, MD, Phd
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Body Weight