<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/NCT02995980</url>
  </required_header>
  <id_info>
    <org_study_id>F141210004</org_study_id>
    <nct_id>NCT02995980</nct_id>
  </id_info>
  <brief_title>Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography</brief_title>
  <official_title>Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital&#xD;
      mammography to detect breast cancer in patients with increased breast density (BI-RADS&#xD;
      category c or d). Eligible patients will be invited to have full-field digital mammography&#xD;
      and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the&#xD;
      imaging methods for the detection of breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital&#xD;
      mammography to detect breast cancer in patients with increased breast density (Breast&#xD;
      Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have&#xD;
      full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital&#xD;
      mammography to compare accuracy of the imaging methods for the detection of breast cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Percent Accuracy of Contrast Mammography</measure>
    <time_frame>1 year</time_frame>
    <description>•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Cancer Detected</measure>
    <time_frame>1 year</time_frame>
    <description>•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Call Backs With Contrast Mammography</measure>
    <time_frame>1 year</time_frame>
    <description>•The patients identified for additional imaging based on unconfirmed findings.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Contrast enhanced mammography vs standard digital mammogram</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contrast-enhanced spectral mammography for the detection breast cancer .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dual-Energy Contrast-Enhanced (DECE) mammography</intervention_name>
    <description>Contrast mammography</description>
    <arm_group_label>Contrast enhanced mammography vs standard digital mammogram</arm_group_label>
    <other_name>Contrast-enhanced spectral mammography (CESM)</other_name>
    <other_name>Contrast-enhanced mammography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>digital mammography</intervention_name>
    <description>routine digital mammography</description>
    <arm_group_label>Contrast enhanced mammography vs standard digital mammogram</arm_group_label>
    <other_name>full field digital mammography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent&#xD;
&#xD;
          2. At least 19 years old&#xD;
&#xD;
          3. Glomerular filtration rate&gt; 60&#xD;
&#xD;
          4. Heterogeneously or extremely dense breasts (BI-RADS category c or d).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of iodinated contrast allergy&#xD;
&#xD;
          2. Pregnant or lactating as determined by routine standard practice&#xD;
&#xD;
          3. Personal history of breast cancer&#xD;
&#xD;
          4. History of prior breast excisional biopsy (Patients with a history of core needle&#xD;
             biopsy will not be excluded)&#xD;
&#xD;
          5. History of prior breast reduction mammoplasty surgery&#xD;
&#xD;
          6. History of prior breast augmentation surgery&#xD;
&#xD;
          7. Mental condition rendering the subject unable to understand the nature, scope, and&#xD;
             possible consequences of the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidi R Umphrey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Kirklin Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>March 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>July 23, 2019</results_first_submitted>
  <results_first_submitted_qc>August 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2019</results_first_posted>
  <last_update_submitted>August 30, 2019</last_update_submitted>
  <last_update_submitted_qc>August 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Rachael Lancaster, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>breast cancer screening</keyword>
  <keyword>dense breasts</keyword>
  <keyword>dual-energy contrast-enhanced digital mammography</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT02995980/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Contrast Enhanced Mammography vs Standard Digital Mammograpm</title>
          <description>Contrast-enhanced spectral mammography for the detection breast cancer .&#xD;
Dual-Energy Contrast-Enhanced (DECE) mammography: Contrast mammography</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>114 patients completed both mammograms</population>
      <group_list>
        <group group_id="B1">
          <title>Contrast Enhanced Mammography vs Standard Digital Mammograpm</title>
          <description>Contrast-enhanced spectral mammography for the detection breast cancer .&#xD;
DECE mammography: Contrast mammography</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="128"/>
          </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="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </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="128"/>
                  </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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Accuracy of Contrast Mammography</title>
        <description>•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).</description>
        <time_frame>1 year</time_frame>
        <population>Consented 128 patients, 114 patients completed both mammograms</population>
        <group_list>
          <group group_id="O1">
            <title>Contrast Enhanced Mammography</title>
            <description>Contrast-enhanced spectral mammography for the detection breast cancer .&#xD;
DECE mammography: Contrast mammography</description>
          </group>
          <group group_id="O2">
            <title>Standard Digital Mammogram</title>
            <description>Full field digital mammography for the detection breast cancer&#xD;
digital mammography: routine digital mammography</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Accuracy of Contrast Mammography</title>
          <description>•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).</description>
          <population>Consented 128 patients, 114 patients completed both mammograms</population>
          <units>percentage of accuracy</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="29" upper_limit="100"/>
                    <measurement group_id="O2" value="67" lower_limit="9" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Cancer Detected</title>
        <description>•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).</description>
        <time_frame>1 year</time_frame>
        <population>Consented 128 patients, 114 patients completed both mammograms</population>
        <group_list>
          <group group_id="O1">
            <title>Contrast Enhanced Mammography</title>
            <description>Contrast-enhanced spectral mammography for the detection breast cancer .&#xD;
DECE mammography: Contrast mammography</description>
          </group>
          <group group_id="O2">
            <title>Standard Digital Mammogram</title>
            <description>Full field digital mammography for the detection breast cancer&#xD;
digital mammography: routine digital mammography</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cancer Detected</title>
          <description>•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).</description>
          <population>Consented 128 patients, 114 patients completed both mammograms</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="114"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Call Backs With Contrast Mammography</title>
        <description>•The patients identified for additional imaging based on unconfirmed findings.</description>
        <time_frame>1 year</time_frame>
        <population>Consented 128 patients, 114 patients completed both mammograms</population>
        <group_list>
          <group group_id="O1">
            <title>Contrast Enhanced Mammography</title>
            <description>Contrast-enhanced spectral mammography for the detection breast cancer .&#xD;
DECE mammography: Contrast mammography</description>
          </group>
          <group group_id="O2">
            <title>Standard Digital Mammogram</title>
            <description>Full field digital mammography for the detection breast cancer&#xD;
digital mammography: routine digital mammography</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Call Backs With Contrast Mammography</title>
          <description>•The patients identified for additional imaging based on unconfirmed findings.</description>
          <population>Consented 128 patients, 114 patients completed both mammograms</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="5" upper_limit="17"/>
                    <measurement group_id="O2" value="11" lower_limit="6" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events will be recorded on the CRFs up to 30 days after administration of the last dose of study treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Contrast Enhanced Mammography vs Standard Digital Mammograpm</title>
          <description>Contrast-enhanced spectral mammography for the detection breast cancer .&#xD;
DECE mammography: Contrast mammography</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="128"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
              </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="128"/>
              </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>Rachael Lancaster, MD</name_or_title>
      <organization>University of Alabama at Birmingahm</organization>
      <phone>205-934-4080</phone>
      <email>mvetrano@uabmc.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/NCT02995980
org study id: F141210004
nct id: NCT02995980
lead sponsor: 
has dmc: No
This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital
      mammography to detect breast cancer in patients with increased breast density (BI-RADS
      category c or d). Eligible patients will be invited to have full-field digital mammography
      and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the
      imaging methods for the detection of breast cancer.
This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital
      mammography to detect breast cancer in patients with increased breast density (Breast
      Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have
      full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital
      mammography to compare accuracy of the imaging methods for the detection of breast cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percent Accuracy of Contrast Mammography
time frame: 1 year
description: •The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).
measure: Number of Participants With Cancer Detected
time frame: 1 year
description: •The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).
measure: Number of Call Backs With Contrast Mammography
time frame: 1 year
description: •The patients identified for additional imaging based on unconfirmed findings.
arm group label: Contrast enhanced mammography vs standard digital mammogram
arm group type: Experimental
description: Contrast-enhanced spectral mammography for the detection breast cancer .
intervention type: Device
intervention name: Dual-Energy Contrast-Enhanced (DECE) mammography
description: Contrast mammography
arm group label: Contrast enhanced mammography vs standard digital mammogram
other name: Contrast-enhanced spectral mammography (CESM)
other name: Contrast-enhanced mammography
intervention type: Device
intervention name: digital mammography
description: routine digital mammography
arm group label: Contrast enhanced mammography vs standard digital mammogram
other name: full field digital mammography
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Heidi R Umphrey, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Rachael Lancaster, MD
investigator title: MD
mesh term: Breast Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 