<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/NCT01687790</url>
  </required_header>
  <id_info>
    <org_study_id>PRO12030005</org_study_id>
    <nct_id>NCT01687790</nct_id>
  </id_info>
  <brief_title>The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease</brief_title>
  <official_title>The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary hypothesis of this project is that using molecular breast imaging (MBI) in&#xD;
      evaluating women with equivocal mammographic or sonographic findings will demonstrate high&#xD;
      specificity in distinguishing benign from malignant breast disease and, as a result, decrease&#xD;
      the number of biopsies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.</measure>
    <time_frame>1 year</time_frame>
    <description>The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.</measure>
    <time_frame>1 year</time_frame>
    <description>Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Abnormalities</condition>
  <arm_group>
    <arm_group_label>molecular breast imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>molecular breast imaging (Discovery)</intervention_name>
    <arm_group_label>molecular breast imaging</arm_group_label>
    <other_name>Discovery NM750b</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Women who have indeterminate mammographic or sonographic findings who are recommended&#xD;
             and for biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known contraindication to mammographic imaging&#xD;
&#xD;
          -  women who are pregnant&#xD;
&#xD;
          -  women who are lactating&#xD;
&#xD;
          -  women who have significant existing breast trauma&#xD;
&#xD;
          -  women who have breast implants&#xD;
&#xD;
          -  Women under 18 years of age.&#xD;
&#xD;
          -  women who had previous benign breast surgery within 1 year&#xD;
&#xD;
          -  Males and children&#xD;
&#xD;
          -  Women who are unable to understand or execute written informed consent&#xD;
&#xD;
          -  Women who refuse to have a biopsy&#xD;
&#xD;
          -  Women with any known renal disease - if an MRI is deemed necessary, a serum creatine&#xD;
             will be checked prior to injection of contrast. Using the National Kidney Foundation&#xD;
             recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive&#xD;
             intravenous gadolinium-based MRI contrast. Those individuals with a GFR &gt;30 and &lt;60&#xD;
             can receive the contrast but at a reduced dose (typically half). Those with a GFR &lt;30&#xD;
             will not receive MRI contrast and will not undergo the exam. Breast MRI must be done&#xD;
             with contrast if evaluating for cancer. Several factors can affect the GFR such as&#xD;
             age, body size, creatinine, renal status and will be calculated from the blood drawn.&#xD;
             GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that&#xD;
             precludes a Breast MRI with contrast. The final determinant will be the GFR.&#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>Christiane Hakim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>January 27, 2016</results_first_submitted>
  <results_first_submitted_qc>July 31, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 20, 2016</results_first_posted>
  <last_update_submitted>July 31, 2016</last_update_submitted>
  <last_update_submitted_qc>July 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Christiane Hakim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>molecular breast imaging</keyword>
  <keyword>breast disease</keyword>
  <keyword>breast biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>single group</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Molecular Breast Imaging</title>
          <description>molecular breast imaging (Discovery)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Women scheduled for biopsy based on a suspicious mammogram and/or ultrasound. MBI results were compared to pathology.</population>
      <group_list>
        <group group_id="B1">
          <title>Molecular Breast Imaging</title>
          <description>molecular breast imaging (Discovery)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
          </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="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" lower_limit="33" upper_limit="78"/>
                  </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="60"/>
                  </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="2"/>
                  </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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </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>
          <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="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.</title>
        <description>The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).</description>
        <time_frame>1 year</time_frame>
        <population>Analysis population included the number of indeterminate lesions that had negative/benign pathology results.</population>
        <group_list>
          <group group_id="O1">
            <title>Molecular Breast Imaging</title>
            <description>Participants received molecular breast imaging before biopsy</description>
          </group>
        </group_list>
        <measure>
          <title>Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.</title>
          <description>The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).</description>
          <population>Analysis population included the number of indeterminate lesions that had negative/benign pathology results.</population>
          <units>lesions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.</title>
        <description>Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).</description>
        <time_frame>1 year</time_frame>
        <population>Analysis population included the number of indeterminate lesions that had positive pathology results.</population>
        <group_list>
          <group group_id="O1">
            <title>Molecular Breast Imaging</title>
            <description>molecular breast imaging (Discovery)</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.</title>
          <description>Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).</description>
          <population>Analysis population included the number of indeterminate lesions that had positive pathology results.</population>
          <units>lesions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Molecular Breast Imaging</title>
          <description>molecular breast imaging (Discovery)</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="60"/>
              </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="60"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Christiane Hakim</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-641-1965</phone>
      <email>chakim@magee.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/NCT01687790
org study id: PRO12030005
nct id: NCT01687790
lead sponsor: 
collaborator: 
has dmc: No
The primary hypothesis of this project is that using molecular breast imaging (MBI) in
      evaluating women with equivocal mammographic or sonographic findings will demonstrate high
      specificity in distinguishing benign from malignant breast disease and, as a result, decrease
      the number of biopsies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.
time frame: 1 year
description: The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).
measure: Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.
time frame: 1 year
description: Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).
arm group label: molecular breast imaging
arm group type: Experimental
intervention type: Device
intervention name: molecular breast imaging (Discovery)
arm group label: molecular breast imaging
other name: Discovery NM750b
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christiane Hakim, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Christiane Hakim
investigator title: Principal Investigator
mesh term: Breast Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 