<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/NCT02183597</url>
  </required_header>
  <id_info>
    <org_study_id>STUC-2013-WBMRI-Sitter</org_study_id>
    <nct_id>NCT02183597</nct_id>
  </id_info>
  <brief_title>Whole-body MRI for the Detection of Metastasis</brief_title>
  <acronym>WBMRI</acronym>
  <official_title>Whole-body MRI for the Detection of Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate&#xD;
      diagnostic accuracy through application of optimized protocols for screening of cancer&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of metastasis in skeleton</measure>
    <time_frame>Baseline and after 6 months</time_frame>
    <description>Number of skeleton metastasis will be assessed at the regular clinical follow-up of breast cancer patients with metastatic disease</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Metastases</condition>
  <arm_group>
    <arm_group_label>Advanced breast cancer</arm_group_label>
    <description>Women with advanced breast cancer</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women in Mid Norway living with advanced breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Cancer patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor general condition&#xD;
&#xD;
          -  Pacemaker or other MRI contraindications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beathe Sitter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <removed_countries>
    <country>Norway</country>
  </removed_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>May 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>August 8, 2016</last_update_submitted>
  <last_update_submitted_qc>August 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Data Accuracy</keyword>
  <keyword>Reproducibility of Results</keyword>
  <keyword>Diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02183597
org study id: STUC-2013-WBMRI-Sitter
nct id: NCT02183597
lead sponsor: 
has dmc: No
Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate
      diagnostic accuracy through application of optimized protocols for screening of cancer
      patients.
observational model: Cohort
time perspective: Retrospective
measure: Number of metastasis in skeleton
time frame: Baseline and after 6 months
description: Number of skeleton metastasis will be assessed at the regular clinical follow-up of breast cancer patients with metastatic disease
arm group label: Advanced breast cancer
description: Women with advanced breast cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Beathe Sitter, PhD
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
country: Norway
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
sharing ipd: Undecided