<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/NCT03041298</url>
  </required_header>
  <id_info>
    <org_study_id>DGD-55-006</org_study_id>
    <nct_id>NCT03041298</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography</brief_title>
  <official_title>Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guerbet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guerbet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic&#xD;
      Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from&#xD;
      September 2011 to December 2013. The aim of this study, which was conducted in accordance&#xD;
      with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to&#xD;
      generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in&#xD;
      Magnetic Resonance (MR) mammography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from&#xD;
      &quot;excellent&quot; to &quot;very poor&quot;), diagnosis and cytology test result. Safety was assessed on the&#xD;
      basis of the frequency and seriousness of adverse drug reactions observed following the&#xD;
      injection of Dotarem.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Image Quality</measure>
    <time_frame>During MRI procedure</time_frame>
    <description>Image quality was evaluated on a 5-point scale: &quot;excellent&quot;; &quot;good&quot;; &quot;moderate&quot;; &quot;poor&quot; and &quot;very poor&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ability to Make a Diagnosis</measure>
    <time_frame>During MRI procedure</time_frame>
    <description>Ability to make a diagnosis was evaluated by answering &quot;yes&quot; or &quot;no&quot; to the question &quot;Did the examination permit a diagnosis ?&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic Results (Percentage of Patients Per Diagnosis)</measure>
    <time_frame>During MRI procedure</time_frame>
    <description>Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cytology Test Results (Percentage of Patients Per Cytology Test Result)</measure>
    <time_frame>During MRI procedure</time_frame>
    <description>Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Adverse Drug Reactions</measure>
    <time_frame>From the beginning of the MR mammography procedure to 30-60 min after</time_frame>
    <description>The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1537</enrollment>
  <condition>MR Mammography With Dotarem</condition>
  <arm_group>
    <arm_group_label>All included patients</arm_group_label>
    <description>All included patients underwent MR mammography with Dotarem</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MR mammography with Dotarem</intervention_name>
    <arm_group_label>All included patients</arm_group_label>
    <other_name>MR mammography with gadoteric acid/gadoterate meglumine</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult and pediatric patients who are scheduled for high-resolution MR mammography using the&#xD;
        MRI contrast agent Dotarem&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are scheduled for high-resolution MR mammography using the MRI contrast&#xD;
             agent Dotarem&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>March 22, 2017</results_first_submitted>
  <results_first_submitted_qc>March 22, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 2, 2017</results_first_posted>
  <last_update_submitted>March 22, 2017</last_update_submitted>
  <last_update_submitted_qc>March 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Included Patients</title>
          <description>All included patients underwent MR mammography with Dotarem.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1537"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1537"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>All Included Patients</title>
          <description>All included patients underwent MR mammography with Dotarem.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1537"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1537"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.4" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;25 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1537"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>between 25 and 55 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1537"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;55 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1537"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Gender was missing for 43 patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1494"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1491"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Menopausal status</title>
          <description>Menopausal status was recorded before MR mammography.</description>
          <population>Menopausal status was missing for 31 patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Premenopausal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perimenopausal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postmenopausal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="826"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Risk factors</title>
          <description>Risk factors were recorded before MR mammography.</description>
          <population>Risk factors were missing for 270 patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Family history</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1267"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Personal history</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1267"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family and personal history</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1267"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1267"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Image Quality</title>
        <description>Image quality was evaluated on a 5-point scale: &quot;excellent&quot;; &quot;good&quot;; &quot;moderate&quot;; &quot;poor&quot; and &quot;very poor&quot;.</description>
        <time_frame>During MRI procedure</time_frame>
        <population>Image quality was missing for 16 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>All Included Patients</title>
            <description>All included patients underwent MR mammography with Dotarem.</description>
          </group>
        </group_list>
        <measure>
          <title>Image Quality</title>
          <description>Image quality was evaluated on a 5-point scale: &quot;excellent&quot;; &quot;good&quot;; &quot;moderate&quot;; &quot;poor&quot; and &quot;very poor&quot;.</description>
          <population>Image quality was missing for 16 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="1521"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ability to Make a Diagnosis</title>
        <description>Ability to make a diagnosis was evaluated by answering &quot;yes&quot; or &quot;no&quot; to the question &quot;Did the examination permit a diagnosis ?&quot;</description>
        <time_frame>During MRI procedure</time_frame>
        <population>Ability to make a diagnosis was missing for 2 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>All Included Patients</title>
            <description>All included patients underwent MR mammography with Dotarem.</description>
          </group>
        </group_list>
        <measure>
          <title>Ability to Make a Diagnosis</title>
          <description>Ability to make a diagnosis was evaluated by answering &quot;yes&quot; or &quot;no&quot; to the question &quot;Did the examination permit a diagnosis ?&quot;</description>
          <population>Ability to make a diagnosis was missing for 2 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="1535"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1523"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diagnostic Results (Percentage of Patients Per Diagnosis)</title>
        <description>Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.</description>
        <time_frame>During MRI procedure</time_frame>
        <population>Diagnosis was achieved in 1523 patients but results were missing for 4 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>All Included Patients</title>
            <description>All included patients underwent MR mammography with Dotarem.</description>
          </group>
        </group_list>
        <measure>
          <title>Diagnostic Results (Percentage of Patients Per Diagnosis)</title>
          <description>Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.</description>
          <population>Diagnosis was achieved in 1523 patients but results were missing for 4 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="1519"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Benign changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal findings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unilateral focal pathological findings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Invasive ductal carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilateral focal pathological findings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carcinoma in situ</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extensive intraductal component</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cytology Test Results (Percentage of Patients Per Cytology Test Result)</title>
        <description>Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.</description>
        <time_frame>During MRI procedure</time_frame>
        <population>A cytology test was performed in 232 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>All Included Patients</title>
            <description>All included patients underwent MR mammography with Dotarem.</description>
          </group>
        </group_list>
        <measure>
          <title>Cytology Test Results (Percentage of Patients Per Cytology Test Result)</title>
          <description>Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.</description>
          <population>A cytology test was performed in 232 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="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Invasive ductal carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Invasive lobular carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraductal carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fibroadenoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mucinous carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inflammatory carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Papilloma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medullary carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Invasive papillary carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tubular carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Adverse Drug Reactions</title>
        <description>The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.</description>
        <time_frame>From the beginning of the MR mammography procedure to 30-60 min after</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Included Patients</title>
            <description>All included patients underwent MR mammography with Dotarem.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Adverse Drug Reactions</title>
          <description>The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.</description>
          <units>Adverse drug reactions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1537"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the beginning of the MR mammography procedure to 30-60 min after</time_frame>
      <desc>Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Included Patients</title>
          <description>All included patients underwent MR mammography with Dotarem.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="1537"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <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="4" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting projectile</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
              <event>
                <sub_title>Throat tightness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1537"/>
              </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>Oliver Heine, MD, Radiology &amp; Scientific Affairs Manager</name_or_title>
      <organization>Guerbet GmbH</organization>
      <phone>+49 6196 76250</phone>
      <email>oliver.heine@guerbet-group.com</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/NCT03041298
org study id: DGD-55-006
nct id: NCT03041298
lead sponsor: 
has dmc: No
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic
      Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from
      September 2011 to December 2013. The aim of this study, which was conducted in accordance
      with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to
      generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in
      Magnetic Resonance (MR) mammography.
Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from
      "excellent" to "very poor"), diagnosis and cytology test result. Safety was assessed on the
      basis of the frequency and seriousness of adverse drug reactions observed following the
      injection of Dotarem.
observational model: Cohort
time perspective: Prospective
measure: Image Quality
time frame: During MRI procedure
description: Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
measure: Ability to Make a Diagnosis
time frame: During MRI procedure
description: Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"
measure: Diagnostic Results (Percentage of Patients Per Diagnosis)
time frame: During MRI procedure
description: Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.
measure: Cytology Test Results (Percentage of Patients Per Cytology Test Result)
time frame: During MRI procedure
description: Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.
measure: Frequency of Adverse Drug Reactions
time frame: From the beginning of the MR mammography procedure to 30-60 min after
description: The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.
arm group label: All included patients
description: All included patients underwent MR mammography with Dotarem
intervention type: Procedure
intervention name: MR mammography with Dotarem
arm group label: All included patients
other name: MR mammography with gadoteric acid/gadoterate meglumine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 