<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/NCT01713049</url>
  </required_header>
  <id_info>
    <org_study_id>201001043M</org_study_id>
    <nct_id>NCT01713049</nct_id>
  </id_info>
  <brief_title>18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound</brief_title>
  <official_title>Use of 18F-FLT Positron Emission Tomography to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions&#xD;
      on mammograms and ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on&#xD;
           mammograms and ultrasound, using the pathologic result of biopsy as gold standard, and&#xD;
           to determine whether 18F-FLT PET can increase the specificity in breast lesion diagnosis&#xD;
           and thus reduce the unnecessary biopsy.&#xD;
&#xD;
        2. To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer&#xD;
           diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2010</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard.</measure>
    <time_frame>The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET.</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>18F-FLT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-FLT</intervention_name>
    <description>0.07 mCi/kg of 18F-FDG will be injected intravenously. The data acquisition will be started at 90 minutes after the injection using 2-D acquisition from a GE DISCOVERY ST PET/CT scanner (GE Medical Systems, Milwaukee, WI).</description>
    <arm_group_label>18F-FLT</arm_group_label>
    <other_name>FLT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged between 20 to 80 years&#xD;
&#xD;
          2. women who have localized findings on mammography and / or ultrasound and will receive&#xD;
             biopsy.&#xD;
&#xD;
          3. The lesions on the conventional imaging measure &gt;=1cm&#xD;
&#xD;
          4. WBC count &gt;=3000/L, or platelet&gt;=75,000/L&#xD;
&#xD;
          5. Liver function, AST or ALT &lt; 78 U/L&#xD;
&#xD;
          6. Renal function, Creatinine &lt; 2.0 mg/dl.The laboratory examinations should be performed&#xD;
             within 4months before our study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women or who are planning to be pregnant.&#xD;
&#xD;
          2. Known cancers in other organs.&#xD;
&#xD;
          3. Women who are not able to cooperate with the PET/CT examination.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medical Imaging NTUH</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jane Wang, MD, PhD</last_name>
      <phone>+886-2-23123456</phone>
      <phone_ext>65565</phone_ext>
      <email>hstjen@yahoo.com.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2010</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 23, 2012</last_update_submitted>
  <last_update_submitted_qc>October 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>National Taiwan University Hospital</investigator_full_name>
    <investigator_title>National Taiwan University Hospital</investigator_title>
  </responsible_party>
  <keyword>FLT PET</keyword>
  <keyword>breast neoplasms</keyword>
  <keyword>mammography</keyword>
  <keyword>breast ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alovudine</mesh_term>
  </intervention_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/NCT01713049
org study id: 201001043M
nct id: NCT01713049
lead sponsor: 
has dmc: Yes
The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions
      on mammograms and ultrasound.
1. To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on
           mammograms and ultrasound, using the pathologic result of biopsy as gold standard, and
           to determine whether 18F-FLT PET can increase the specificity in breast lesion diagnosis
           and thus reduce the unnecessary biopsy.

        2. To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer
           diagnosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard.
time frame: The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET.
arm group label: 18F-FLT
arm group type: Other
description: 18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound.
intervention type: Drug
intervention name: 18F-FLT
description: 0.07 mCi/kg of 18F-FDG will be injected intravenously. The data acquisition will be started at 90 minutes after the injection using 2-D acquisition from a GE DISCOVERY ST PET/CT scanner (GE Medical Systems, Milwaukee, WI).
arm group label: 18F-FLT
other name: FLT
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jane Wang, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: National Taiwan University Hospital
investigator title: National Taiwan University Hospital
mesh term: Breast Neoplasms
mesh term: Alovudine