<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/NCT02212834</url>
  </required_header>
  <id_info>
    <org_study_id>CE-1304-6656</org_study_id>
    <nct_id>NCT02212834</nct_id>
  </id_info>
  <brief_title>Surveillance Imaging Modalities for Breast Cancer Assessment</brief_title>
  <acronym>SIMBA</acronym>
  <official_title>Comparative Effectiveness of Surveillance Modalities in Breast Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dartmouth College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Pilgrim Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of surveillance breast MRI&#xD;
      compared to mammography alone in women with a personal history of breast cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our overall aim is to find out how well MRI works compared with mammography for surveillance&#xD;
      in women who have previously had breast cancer. Specifically, our goals are to:&#xD;
&#xD;
        1. Understand doctors' and patients' experiences with surveillance mammography and MRI&#xD;
&#xD;
        2. Provide evidence on which outcomes are more or less likely to occur&#xD;
&#xD;
        3. Develop patient decision aids to help women and their doctors choose the surveillance&#xD;
           method that is right for them&#xD;
&#xD;
      How we will conduct the study: We will work with patients, doctors, policy makers, advocacy&#xD;
      groups, and researchers to improve surveillance for women who have a personal history of&#xD;
      breast cancer. Through focus groups with patients and interviews with doctors, we will gain&#xD;
      insights into women's experience with surveillance mammography and MRI. We will also compare&#xD;
      mammography to MRI using data from the Breast Cancer Surveillance Consortium-the largest&#xD;
      collection of breast cancer surveillance data in the nation. We will use data from more than&#xD;
      13,000 women diagnosed with breast cancer between 2005 and 2012 to determine how well each&#xD;
      test works. We will measure the tests' effectiveness at finding second cancers, and estimate&#xD;
      the likelihood of different outcomes. We will also determine whether one test appears to work&#xD;
      better than the other to detect second breast cancers among different groups of women. We&#xD;
      will then develop patient decision aids to help women and their doctors make more-informed&#xD;
      choices about surveillance.&#xD;
&#xD;
      What we hope to achieve: We hope this study will improve medical decision making and care for&#xD;
      the 3 million women in the United States who have a history of breast cancer. Specifically,&#xD;
      our results will help women and their doctors make clearer, better choices about the&#xD;
      surveillance method that is right for them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Breast Cancers Detected</measure>
    <time_frame>12 months post surveillance exam</time_frame>
    <description>Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">36444</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Mammograms</arm_group_label>
    <description>Surveillance mammograms in women with a personal history of breast cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breast MRI</arm_group_label>
    <description>Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Surveillance imaging exams in women included in the Breast Cancer Surveillance Consortium&#xD;
        who are 18+ years of age at the the of a Stage 0-III incident breast cancer diagnosis&#xD;
        between January 1, 2005 and December 31, 2012.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Surveillance imaging exams in women included in the Breast Cancer&#xD;
        Surveillance Consortium who are 18+ years of age at the the of a Stage 0-III incident&#xD;
        breast cancer diagnosis between January 1, 2005 and December 31, 2012.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with a diagnosis of lobular carcinoma in situ&#xD;
&#xD;
          -  Women with missing cancer staging data from Surveillance, Epidemiology and End Results&#xD;
             (SEER) Program records&#xD;
&#xD;
          -  Women with Stage 4 breast cancer at time of diagnosis&#xD;
&#xD;
          -  Women with a diagnosis of a second breast cancer event within six months of the&#xD;
             primary diagnosis&#xD;
&#xD;
          -  Women who die within six months of primary diagnosis&#xD;
&#xD;
          -  Women who have had a double mastectomy&#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>Karen J. Wernli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Group Health Research Institute</affiliation>
  </overall_official>
  <link>
    <url>https://www.artefactgroup.com/work/simba-breast-cancer-decisions-aid/</url>
    <description>SIMBA Decision tool</description>
  </link>
  <link>
    <url>https://vimeo.com/154765251</url>
    <description>Video of impact of patient engagement in research</description>
  </link>
  <reference>
    <citation>Johnson DS, Bush MT, Brandzel S, Wernli KJ. The patient voice in research-evolution of a role. Res Involv Engagem. 2016 Feb 22;2:6. doi: 10.1186/s40900-016-0020-4. eCollection 2016.</citation>
    <PMID>29062507</PMID>
  </reference>
  <reference>
    <citation>Henderson LM, Ichikawa L, Buist DSM, Lee JM, Bush M, Johnson D, Onega T, Nekhlyudov L, Kerlikowske K, Miglioretti DL, Sprague BL, Wernli KJ. Patterns of Breast Imaging Use Among Women with a Personal History of Breast Cancer. J Gen Intern Med. 2019 Oct;34(10):2098-2106. doi: 10.1007/s11606-019-05181-6. Epub 2019 Aug 13.</citation>
    <PMID>31410813</PMID>
  </reference>
  <results_reference>
    <citation>Wernli KJ, Ichikawa L, Kerlikowske K, Buist DSM, Brandzel SD, Bush M, Johnson D, Henderson LM, Nekhlyudov L, Onega T, Sprague BL, Lee JM, Lehman CD, Miglioretti DL. Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Breast Cancer. Radiology. 2019 Aug;292(2):311-318. doi: 10.1148/radiol.2019182475. Epub 2019 Jun 4.</citation>
    <PMID>31161975</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>March 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <results_first_submitted>November 28, 2016</results_first_submitted>
  <results_first_submitted_qc>December 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 7, 2017</results_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast</keyword>
  <keyword>Cancer</keyword>
  <keyword>Surveillance</keyword>
  <keyword>Imaging</keyword>
  <keyword>Comparative</keyword>
  <keyword>Effectiveness</keyword>
  <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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Cohort analysis of women with one or more observed breast cancer surveillance exams and primary cancer diagnosis between 2003 and 2012</recruitment_details>
      <pre_assignment_details>Not a clinical trial. Analyses were conducted with the entire population who met study criteria. Unit of analysis was surveillance exam.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mammograms</title>
          <description>Surveillance mammograms in women with a personal history of breast cancer</description>
        </group>
        <group group_id="P2">
          <title>Breast MRI</title>
          <description>Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33938"/>
                <participants group_id="P2" count="2506"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33938"/>
                <participants group_id="P2" count="2506"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Characteristics at time of surveillance exam</population>
      <group_list>
        <group group_id="B1">
          <title>Mammograms</title>
          <description>Surveillance mammograms in women with a personal history of breast cancer</description>
        </group>
        <group group_id="B2">
          <title>Breast MRI</title>
          <description>Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33,938"/>
            <count group_id="B2" value="2,506"/>
            <count group_id="B3" value="36444"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>surveillance exams</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33938"/>
            <count group_id="B2" value="2506"/>
            <count group_id="B3" value="36444"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>surveillance exams</units>
          <param>Count of Units</param>
          <units_analyzed>surveillance exams</units_analyzed>
          <class_list>
            <class>
              <title>Age at exam</title>
              <category_list>
                <category>
                  <title>18 - 39 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="388"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="541"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40 - 49 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3,635"/>
                    <measurement group_id="B2" value="574"/>
                    <measurement group_id="B3" value="4209"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50 - 59 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8,626"/>
                    <measurement group_id="B2" value="1,005"/>
                    <measurement group_id="B3" value="9631"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60 - 69 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9,852"/>
                    <measurement group_id="B2" value="632"/>
                    <measurement group_id="B3" value="10484"/>
                  </measurement_list>
                </category>
                <category>
                  <title>70 - 79 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7,167"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="7300"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; or = 80 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4,270"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="4279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>surveillance exams</units>
          <param>Count of Units</param>
          <units_analyzed>surveillance exams</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33,938"/>
                    <measurement group_id="B2" value="2,506"/>
                    <measurement group_id="B3" value="36444"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>surveillance exams</units>
          <param>Count of Units</param>
          <units_analyzed>surveillance exams</units_analyzed>
          <class_list>
            <class>
              <title>Race/ethnicity at time of exam</title>
              <category_list>
                <category>
                  <title>White, non-hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26,717"/>
                    <measurement group_id="B2" value="2,069"/>
                    <measurement group_id="B3" value="28786"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black, non-hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2,862"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="2924"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1,042"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="1109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2,583"/>
                    <measurement group_id="B2" value="219"/>
                    <measurement group_id="B3" value="2802"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed or Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="657"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="745"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Breast Cancers Detected</title>
        <description>Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI</description>
        <time_frame>12 months post surveillance exam</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mammograms</title>
            <description>Surveillance mammograms in women with a personal history of breast cancer</description>
          </group>
          <group group_id="O2">
            <title>Breast MRI</title>
            <description>Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Breast Cancers Detected</title>
          <description>Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI</description>
          <units>cancers detected</units>
          <param>Number</param>
          <units_analyzed>exams</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33,938"/>
                <count group_id="O2" value="2,506"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>exams</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33938"/>
                <count group_id="O2" value="2506"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="279"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>This study was not a clinical trial. It was a cohort analysis, with no study intervention and no participant contact. Adverse events are not applicable.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mammograms</title>
          <description>Surveillance mammograms in women with a personal history of breast cancer</description>
        </group>
        <group group_id="E2">
          <title>Breast MRI</title>
          <description>Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was not a clinical trial. It was a cohort analysis of existing data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Karen J. Wernli, PhD</name_or_title>
      <organization>Group Health Research Institute</organization>
      <phone>206-287-2934</phone>
      <email>wernli.k@ghc.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02212834
org study id: CE-1304-6656
nct id: NCT02212834
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine the effectiveness of surveillance breast MRI
      compared to mammography alone in women with a personal history of breast cancer
Our overall aim is to find out how well MRI works compared with mammography for surveillance
      in women who have previously had breast cancer. Specifically, our goals are to:

        1. Understand doctors' and patients' experiences with surveillance mammography and MRI

        2. Provide evidence on which outcomes are more or less likely to occur

        3. Develop patient decision aids to help women and their doctors choose the surveillance
           method that is right for them

      How we will conduct the study: We will work with patients, doctors, policy makers, advocacy
      groups, and researchers to improve surveillance for women who have a personal history of
      breast cancer. Through focus groups with patients and interviews with doctors, we will gain
      insights into women's experience with surveillance mammography and MRI. We will also compare
      mammography to MRI using data from the Breast Cancer Surveillance Consortium-the largest
      collection of breast cancer surveillance data in the nation. We will use data from more than
      13,000 women diagnosed with breast cancer between 2005 and 2012 to determine how well each
      test works. We will measure the tests' effectiveness at finding second cancers, and estimate
      the likelihood of different outcomes. We will also determine whether one test appears to work
      better than the other to detect second breast cancers among different groups of women. We
      will then develop patient decision aids to help women and their doctors make more-informed
      choices about surveillance.

      What we hope to achieve: We hope this study will improve medical decision making and care for
      the 3 million women in the United States who have a history of breast cancer. Specifically,
      our results will help women and their doctors make clearer, better choices about the
      surveillance method that is right for them.
observational model: Cohort
time perspective: Retrospective
measure: Number of Breast Cancers Detected
time frame: 12 months post surveillance exam
description: Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI
arm group label: Mammograms
description: Surveillance mammograms in women with a personal history of breast cancer
arm group label: Breast MRI
description: Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen J. Wernli, PhD
role: Principal Investigator
affiliation: Group Health Research Institute
url: https://www.artefactgroup.com/work/simba-breast-cancer-decisions-aid/
description: SIMBA Decision tool
url: https://vimeo.com/154765251
description: Video of impact of patient engagement in research
citation: Johnson DS, Bush MT, Brandzel S, Wernli KJ. The patient voice in research-evolution of a role. Res Involv Engagem. 2016 Feb 22;2:6. doi: 10.1186/s40900-016-0020-4. eCollection 2016.
PMID: 29062507
citation: Henderson LM, Ichikawa L, Buist DSM, Lee JM, Bush M, Johnson D, Onega T, Nekhlyudov L, Kerlikowske K, Miglioretti DL, Sprague BL, Wernli KJ. Patterns of Breast Imaging Use Among Women with a Personal History of Breast Cancer. J Gen Intern Med. 2019 Oct;34(10):2098-2106. doi: 10.1007/s11606-019-05181-6. Epub 2019 Aug 13.
PMID: 31410813
citation: Wernli KJ, Ichikawa L, Kerlikowske K, Buist DSM, Brandzel SD, Bush M, Johnson D, Henderson LM, Nekhlyudov L, Onega T, Sprague BL, Lee JM, Lehman CD, Miglioretti DL. Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Breast Cancer. Radiology. 2019 Aug;292(2):311-318. doi: 10.1148/radiol.2019182475. Epub 2019 Jun 4.
PMID: 31161975
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was not a clinical trial. It was a cohort analysis of existing data.
point of contact: 