<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/NCT03243435</url>
  </required_header>
  <id_info>
    <org_study_id>2016-00808</org_study_id>
    <nct_id>NCT03243435</nct_id>
  </id_info>
  <brief_title>Sienna+MR Long-term Uptake</brief_title>
  <official_title>Feasibility of Breast MRI After Sentinel Procedure for Breast Cancer With Superparamagnetic Tracers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Baden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Baden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for&#xD;
      sentinel lymph node detection. In this follow up study we want to investigate how much of&#xD;
      this tracer is still detectable.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>I) Analysis if the supraparamegnetic Tracer is still detectable</measure>
    <time_frame>04/2017</time_frame>
    <description>Analysis by two expert radiologists</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis to which degree of impairment of Imaging is detected</measure>
    <time_frame>04/2017</time_frame>
    <description>Description as &quot;no impairment&quot;, impairment, but Interpretation of Images possible&quot;, &quot;impairment, Image Interpretation impossible&quot;</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Native 1,5 Tesla breast MRI group</arm_group_label>
    <description>From all patients a 1,5 Tesla MRI of the breast will be obtained</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Native 1,5 Tesla breast MRI</intervention_name>
    <arm_group_label>Native 1,5 Tesla breast MRI group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all 34 patients from the previous study are included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        inclusion:&#xD;
&#xD;
          -  participation in previous study&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  no contraindications for MRI scan&#xD;
&#xD;
        exclusion:&#xD;
&#xD;
          -  contraindications for MRI scan&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kantonsspital Baden</name>
      <address>
        <city>Baden</city>
        <state>Aargau</state>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 5, 2016</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Baden</investigator_affiliation>
    <investigator_full_name>Cornelia Leo</investigator_full_name>
    <investigator_title>Head, Breast Center</investigator_title>
  </responsible_party>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03243435
org study id: 2016-00808
nct id: NCT03243435
lead sponsor: 
has dmc: No
In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for
      sentinel lymph node detection. In this follow up study we want to investigate how much of
      this tracer is still detectable.
observational model: Case-Only
time perspective: Prospective
measure: I) Analysis if the supraparamegnetic Tracer is still detectable
time frame: 04/2017
description: Analysis by two expert radiologists
measure: Analysis to which degree of impairment of Imaging is detected
time frame: 04/2017
description: Description as "no impairment", impairment, but Interpretation of Images possible", "impairment, Image Interpretation impossible"
arm group label: Native 1,5 Tesla breast MRI group
description: From all patients a 1,5 Tesla MRI of the breast will be obtained
intervention type: Procedure
intervention name: Native 1,5 Tesla breast MRI
arm group label: Native 1,5 Tesla breast MRI group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Kantonsspital Baden
investigator full name: Cornelia Leo
investigator title: Head, Breast Center
mesh term: Breast Neoplasms
sharing ipd: No