<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/NCT01704547</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00047123</org_study_id>
    <nct_id>NCT01704547</nct_id>
  </id_info>
  <brief_title>Breast Cup Immobilization Device II (GCC 1047)</brief_title>
  <acronym>BCID II</acronym>
  <official_title>Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to assess the accuracy of patient breast reproducibly using the revised&#xD;
      BCID. This study would provide data for target verification and quality assurance to&#xD;
      eventually allow treatment of breast cancer patients for either a TBB or accelerated partial&#xD;
      breast irradiation. The BCID is a low-risk device similar to immobilization devices used&#xD;
      routinely in radiotherapy for other disease sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast conserving therapy (BCT) has become the standard of care for treating early-stage&#xD;
      breast cancers based on six prospective randomized trials with 20 years of follow-up data&#xD;
      (Fisher). During lumpectomy, the surgeon removes the tumor and a surrounding rim of normal&#xD;
      tissue (margin), leaving surgical clips to help designate the resection bed. Radiation&#xD;
      treatment is directed at the whole breast for 5 1/2 weeks and is generally followed by a 1-2&#xD;
      week boost directed at the lumpectomy site plus a margin of normal breast tissue. The benefit&#xD;
      of adding the tumor bed boost, (TBB) has been shown in two studies to decrease local failures&#xD;
      [Romestaig; Bartelink].&#xD;
&#xD;
      Studies have evaluated the role of radiation following lumpectomy in very select groups which&#xD;
      have not been able to define a group who do not benefit from the addition of radiotherapy. In&#xD;
      the group of patients who received surgery alone, 85% of the breast recurrences occurred in&#xD;
      the tumor bed. Due to these two facts, radiotherapy directed only at the tumor bed has been&#xD;
      evaluated. Treating this smaller tumor volume has allowed higher doses of radiation to be&#xD;
      delivered safely shortening the treatment course from 6-7 weeks to one week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Breast Cup Immobilization Device II (GCC 1047) Feasibility</measure>
    <time_frame>One year</time_frame>
    <description>Complete clinical feasibility of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy. Measurements were able to be completed on 25 participants through treatment planning CT scans.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breast Cup Immobilization Device II (GCC 1047) Comfort</measure>
    <time_frame>One year</time_frame>
    <description>Assess patient comfort while wearing the breast cup immobilization device. Patients provided questionnaire to rate comfort level (discomfort was ranked from 0 (no pain) to 5 (very painful).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment</measure>
    <time_frame>1 year</time_frame>
    <description>Candidates being assessed based on their breast size, tumor or tumor bed size, tumor or tumor bed location and normal tissue proximity by evaluating GammaPod treatment plans developed using the acquired CT images. Through images, patients were evaluated for their ability to meet the requirements for GammaPod treatment based off the factors mentioned previously.</description>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Breast Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cancer Center, Primary Care Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient must consent to be in the study and have signed an IRB-approved consent&#xD;
             form.&#xD;
&#xD;
          2. The patient must have a diagnosis of invasive or non-invasive breast cancer.&#xD;
&#xD;
          3. The patient must be planned for or have already had breast conservation surgery (i.e.&#xD;
             lumpectomy).&#xD;
&#xD;
        4 Age &gt; 18. 5. There are at least two metal clips in the surgical cavity placed at the time&#xD;
        of surgery for guiding the radiation oncologist in delineating the target of irradiation;&#xD;
        or one radiographic clip placed at the time of stereotactic core needle biopsy with the&#xD;
        intact tumor.&#xD;
&#xD;
        6. Patients who have already been treated by radiation therapy and are being seen in&#xD;
        follow-up can also participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Male gender&#xD;
&#xD;
          2. Patients who cannot be set up comfortably in the prone position (e.g. physical&#xD;
             disability)&#xD;
&#xD;
          3. Tumor/lumpectomy site located in a portion of the breast that cannot be visualized&#xD;
             easily on the CT scan (e.g. superior portion of the upper outer quadrant).&#xD;
&#xD;
          4. Mastectomy was or is the recommended surgical approach.&#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>Elizabeth Nichols, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ummc Msgcc</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>August 23, 2017</results_first_submitted>
  <results_first_submitted_qc>May 2, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 1, 2023</results_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Department of Radiation Oncology</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Lumpectomy</keyword>
  <keyword>Breast Irradiation</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>
      <group_list>
        <group group_id="P1">
          <title>Breastcup</title>
          <description>Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II</population>
      <group_list>
        <group group_id="B1">
          <title>Breastcup</title>
          <description>Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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="25"/>
                  </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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Breast Cup Immobilization Device II (GCC 1047) Feasibility</title>
        <description>Complete clinical feasibility of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy. Measurements were able to be completed on 25 participants through treatment planning CT scans.</description>
        <time_frame>One year</time_frame>
        <population>Analysis was done through imaging assessment. Completed on all 25 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Breastcup</title>
            <description>Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II</description>
          </group>
        </group_list>
        <measure>
          <title>Breast Cup Immobilization Device II (GCC 1047) Feasibility</title>
          <description>Complete clinical feasibility of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy. Measurements were able to be completed on 25 participants through treatment planning CT scans.</description>
          <population>Analysis was done through imaging assessment. Completed on all 25 patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Breast Cup Immobilization Device II (GCC 1047) Comfort</title>
        <description>Assess patient comfort while wearing the breast cup immobilization device. Patients provided questionnaire to rate comfort level (discomfort was ranked from 0 (no pain) to 5 (very painful).</description>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Breastcup</title>
            <description>Assess patient comfort while wearing the breast cup immobilization device and evaluate mock treatment plans for patients using the acquired CT images.</description>
          </group>
        </group_list>
        <measure>
          <title>Breast Cup Immobilization Device II (GCC 1047) Comfort</title>
          <description>Assess patient comfort while wearing the breast cup immobilization device. Patients provided questionnaire to rate comfort level (discomfort was ranked from 0 (no pain) to 5 (very painful).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment</title>
        <description>Candidates being assessed based on their breast size, tumor or tumor bed size, tumor or tumor bed location and normal tissue proximity by evaluating GammaPod treatment plans developed using the acquired CT images. Through images, patients were evaluated for their ability to meet the requirements for GammaPod treatment based off the factors mentioned previously.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Breastcup</title>
            <description>Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment</title>
          <description>Candidates being assessed based on their breast size, tumor or tumor bed size, tumor or tumor bed location and normal tissue proximity by evaluating GammaPod treatment plans developed using the acquired CT images. Through images, patients were evaluated for their ability to meet the requirements for GammaPod treatment based off the factors mentioned previously.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Breastcup</title>
          <description>Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blistering</sub_title>
                <description>Small amount (Grade 1) blistering of the skin related to suction of breast cup</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
              </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>
    <point_of_contact>
      <name_or_title>Elizabeth M. Nichols, MD</name_or_title>
      <organization>UMGCCC</organization>
      <phone>410-328-2324</phone>
      <email>enichols1@umm.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/NCT01704547
org study id: HP-00047123
nct id: NCT01704547
lead sponsor: 
has dmc: Yes
The study is designed to assess the accuracy of patient breast reproducibly using the revised
      BCID. This study would provide data for target verification and quality assurance to
      eventually allow treatment of breast cancer patients for either a TBB or accelerated partial
      breast irradiation. The BCID is a low-risk device similar to immobilization devices used
      routinely in radiotherapy for other disease sites.
Breast conserving therapy (BCT) has become the standard of care for treating early-stage
      breast cancers based on six prospective randomized trials with 20 years of follow-up data
      (Fisher). During lumpectomy, the surgeon removes the tumor and a surrounding rim of normal
      tissue (margin), leaving surgical clips to help designate the resection bed. Radiation
      treatment is directed at the whole breast for 5 1/2 weeks and is generally followed by a 1-2
      week boost directed at the lumpectomy site plus a margin of normal breast tissue. The benefit
      of adding the tumor bed boost, (TBB) has been shown in two studies to decrease local failures
      [Romestaig; Bartelink].

      Studies have evaluated the role of radiation following lumpectomy in very select groups which
      have not been able to define a group who do not benefit from the addition of radiotherapy. In
      the group of patients who received surgery alone, 85% of the breast recurrences occurred in
      the tumor bed. Due to these two facts, radiotherapy directed only at the tumor bed has been
      evaluated. Treating this smaller tumor volume has allowed higher doses of radiation to be
      delivered safely shortening the treatment course from 6-7 weeks to one week.
observational model: Other
time perspective: Prospective
measure: Breast Cup Immobilization Device II (GCC 1047) Feasibility
time frame: One year
description: Complete clinical feasibility of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy. Measurements were able to be completed on 25 participants through treatment planning CT scans.
measure: Breast Cup Immobilization Device II (GCC 1047) Comfort
time frame: One year
description: Assess patient comfort while wearing the breast cup immobilization device. Patients provided questionnaire to rate comfort level (discomfort was ranked from 0 (no pain) to 5 (very painful).
measure: Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment
time frame: 1 year
description: Candidates being assessed based on their breast size, tumor or tumor bed size, tumor or tumor bed location and normal tissue proximity by evaluating GammaPod treatment plans developed using the acquired CT images. Through images, patients were evaluated for their ability to meet the requirements for GammaPod treatment based off the factors mentioned previously.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Nichols, MD
role: Principal Investigator
affiliation: University of Maryland School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Department of Radiation Oncology
investigator title: Principal Investigator
mesh term: Breast Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 