<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/NCT01669148</url>
  </required_header>
  <id_info>
    <org_study_id>2007p-001197</org_study_id>
    <nct_id>NCT01669148</nct_id>
  </id_info>
  <brief_title>Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography</brief_title>
  <official_title>Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hologic, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary hypothesis to be tested is:&#xD;
&#xD;
      The detection of breast cancer will be increased with tomosynthesis (3D) imaging&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if: 1 the detection of breast cancer will be&#xD;
      increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the&#xD;
      detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">June 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of Breast Cancer (Sensitivity)</measure>
    <time_frame>up to two years follow up for development of breast cancer</time_frame>
    <description>Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):&#xD;
Sensitivity = TP / (TP+FN)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">496</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Conventional + Tomosynthesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tomosynthesis alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tomosynthesis</intervention_name>
    <description>The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).</description>
    <arm_group_label>Conventional + Tomosynthesis</arm_group_label>
    <arm_group_label>Tomosynthesis alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional</intervention_name>
    <description>conventional (2D) imaging (standard mammography)</description>
    <arm_group_label>Conventional + Tomosynthesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Any ethnic origin&#xD;
&#xD;
          -  No contraindication for routine bilateral mammography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Potential subjects with any of the following will not be enrolled in the study:&#xD;
&#xD;
          -  Any contraindications to mammographic screening, including, but not limited to:&#xD;
&#xD;
          -  Significant existing breast trauma&#xD;
&#xD;
          -  Under the age of 30 at the time of consent&#xD;
&#xD;
          -  Breast Implants&#xD;
&#xD;
          -  Prior Surgeries&#xD;
&#xD;
               -  Unable to understand and execute written informed consent&#xD;
&#xD;
               -  Pregnant&#xD;
&#xD;
               -  Lactating&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth A Rafferty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MGH</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>April 30, 2010</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <results_first_submitted>April 12, 2017</results_first_submitted>
  <results_first_submitted_qc>May 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 14, 2017</results_first_posted>
  <last_update_submitted>May 19, 2017</last_update_submitted>
  <last_update_submitted_qc>May 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Thomas J. Brady, M.D.</investigator_full_name>
    <investigator_title>Vice Chairman, Radiology Research</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>496 enrolled and 426 completed study, but no information available to distinguish study arms:&#xD;
Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown).&#xD;
Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Study Participants</title>
          <description>All participants enrolled in study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="496"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="426"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>496 participants enrolled overall, but no information available to distinguish study arms:&#xD;
Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown).&#xD;
Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown).</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="496"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="427"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="496"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Detection of Breast Cancer (Sensitivity)</title>
        <description>Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):&#xD;
Sensitivity = TP / (TP+FN)</description>
        <time_frame>up to two years follow up for development of breast cancer</time_frame>
        <population>PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.</population>
        <group_list>
          <group group_id="O1">
            <title>Conventional + Tomosynthesis First Then Tomo Alone 1 mo. Later</title>
            <description>Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).&#xD;
Conventional: conventional (2D) imaging (standard mammography)</description>
          </group>
          <group group_id="O2">
            <title>Tomosynthesis Alone First Then Conventional+Tomo 1 mo. Later</title>
            <description>Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).&#xD;
Conventional: conventional (2D) imaging (standard mammography)</description>
          </group>
        </group_list>
        <measure>
          <title>Detection of Breast Cancer (Sensitivity)</title>
          <description>Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):&#xD;
Sensitivity = TP / (TP+FN)</description>
          <population>PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.&#xD;
496 participants enrolled overall, but no information available to distinguish study arms:&#xD;
Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number enrolled in arm is unknown).&#xD;
Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number enrolled in arm is unknown).</desc>
      <group_list>
        <group group_id="E1">
          <title>All Study Participants</title>
          <description>All participants enrolled in the study</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"/>
              </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"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Thomas J. Brady, MD</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>6177268294</phone>
      <email>tbrady@mgh.harvard.edu</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/NCT01669148
org study id: 2007p-001197
nct id: NCT01669148
lead sponsor: 
collaborator: 
has dmc: No
The primary hypothesis to be tested is:

      The detection of breast cancer will be increased with tomosynthesis (3D) imaging
The purpose of this study is to determine if: 1 the detection of breast cancer will be
      increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the
      detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Detection of Breast Cancer (Sensitivity)
time frame: up to two years follow up for development of breast cancer
description: Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):
Sensitivity = TP / (TP+FN)
arm group label: Conventional + Tomosynthesis
arm group type: Active Comparator
description: conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.
arm group label: Tomosynthesis alone
arm group type: Active Comparator
description: tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.
intervention type: Device
intervention name: Tomosynthesis
description: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
arm group label: Conventional + Tomosynthesis
arm group label: Tomosynthesis alone
intervention type: Device
intervention name: Conventional
description: conventional (2D) imaging (standard mammography)
arm group label: Conventional + Tomosynthesis
criteria: 
gender: Female
minimum age: 35 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth A Rafferty, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Thomas J. Brady, M.D.
investigator title: Vice Chairman, Radiology Research
mesh term: Breast Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.
point of contact: 