<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/NCT01678170</url>
  </required_header>
  <id_info>
    <org_study_id>CIH-LPF-201205001</org_study_id>
    <nct_id>NCT01678170</nct_id>
  </id_info>
  <brief_title>Clinical Application of Breast Blood-oxygen Functional Imaging Technology</brief_title>
  <official_title>Clinical Application of Breast Blood-oxygen Functional Imaging Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is going to evaluate the value of blood-oxygen functional imaging technology in&#xD;
      the diagnosis of breast diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2016</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>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breast Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Female with breast lump, received breast ultrasound and mammography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female older than 18 years breast lump received breast ultrasound and mammography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  After core-needle biopsy or resection After neoadjuvant chemotherapy, radiotherapy or&#xD;
             endocrine therapy&#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>Peifang Liu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Breast Imaging, Tianjin Medical University Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peifang Liu, M.D.</last_name>
    <phone>+86-22-23524536</phone>
    <email>cjr.liupeifang@vip.163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Breast Imaging, Tianjin Medical University Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peifang Liu, M.D.</last_name>
      <phone>+86-22-23524536</phone>
      <email>cjr.liupeifang@vip.163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2012</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>December 21, 2015</last_update_submitted>
  <last_update_submitted_qc>December 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>blood-oxygen functional imaging technology</keyword>
  <keyword>diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT01678170
org study id: CIH-LPF-201205001
nct id: NCT01678170
lead sponsor: 
has dmc: Yes
This trial is going to evaluate the value of blood-oxygen functional imaging technology in
      the diagnosis of breast diseases.
observational model: Case-Only
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peifang Liu, M.D.
role: Principal Investigator
affiliation: Department of Breast Imaging, Tianjin Medical University Cancer Hospital
last name: Peifang Liu, M.D.
phone: +86-22-23524536
email: cjr.liupeifang@vip.163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Breast Diseases