<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/NCT04411966</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG2C0483</org_study_id>
    <nct_id>NCT04411966</nct_id>
  </id_info>
  <brief_title>Early Interim 18F-FDG-PET and 18F-FLT-PET for Predicting Treatment Response and Survival in Metastatic Breast Cancer</brief_title>
  <official_title>Integrating 18F-FDG PET/CT With 18F-FLT PET/CT in Predicting Treatment Response and Prognosis of Metastatic/Recurrent Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      We aim to investigate the value of 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) and&#xD;
      18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT)&#xD;
      for early prediction of treatment response and survival in patients with metastatic breast&#xD;
      cancer after salvage therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with metastatic breast cancer were enrolled and received PET/CT using 18F-FLT and&#xD;
      18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy. The&#xD;
      standard reference for treatment response was classified according to Response Evaluation&#xD;
      Criteria in Solid Tumors (RECIST) 1.1 criteria for contrast-enhanced CT (CE-CT) after 3&#xD;
      months of systemic chemotherapy. The metabolic response on PET was assessed according to PET&#xD;
      response criteria in solid tumors (PERCIST) criteria and was correlated to the treatment&#xD;
      response, progression-free survival (PFS), and overall survival (OS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Participant received 18F-FLT and 18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) maximal standardized uptake value (SUV) as response to therapy</measure>
    <time_frame>Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)</time_frame>
    <description>The response to therapy would be determined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) by contrast-enhanced computed tomography (CE-CT). The change of SUVmax between the responders and non responders on 18F-FLT and 18F-FDG would be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) and European Organization for Research and Treatment of Cancer (EORCT) response by 18F-FLT-PET and 18F-FDG-PET for the prediction of anatomic treatment response</measure>
    <time_frame>Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, , each cycle is 28 days)</time_frame>
    <description>We will use both EORTC and PERCIST criteria to compare the 18F-FLT-PET and 18F-FDG-PET metabolic response for the predictions of anatomic treatment response. Receiver operating characteristic (ROC) curve analysis and comparison were performed to evaluate the performance of 18F-FLT-PET and 18F-FDG-PET in predicting the anatomic treatment response, both with EORTC and PERCIST criteria.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Progression-free survival (PFS) was defined as the time from the date of inclusion in the study to disease recurrence or progression.</measure>
    <time_frame>Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)</time_frame>
    <description>Compare Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) and European Organization for Research and Treatment of Cancer (EORCT) response by 18F-FLT-PET and 18F-FDG-PET for the prediction of survival outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall survival (OS) was defined as the time from the date of inclusion in the study to the date of death from any cause or last follow-up.</measure>
    <time_frame>Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)</time_frame>
    <description>Compare Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) and European Organization for Research and Treatment of Cancer (EORCT) response by 18F-FLT-PET and 18F-FDG-PET for the prediction of survival outcomes</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>18F-fluorothymidine PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes at least 10 days prior to systemic chemotherapy, and at least 10 days after first and second cycles of systemic chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>18F-fluorothymidine</intervention_name>
    <description>Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes at least 10 days prior to systemic chemotherapy, and at least 10 days after first and second cycles of systemic chemotherapy.</description>
    <arm_group_label>18F-fluorothymidine PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have histological evidence of breast cancer of any stage&#xD;
&#xD;
          -  Participants must be diagnosed with metastatic breast cancer&#xD;
&#xD;
          -  Participants should be willing and able to have both PET-CT scans&#xD;
&#xD;
          -  Participants should be eligible for and plan to undergo systemic chemotherapy and&#xD;
             should be seen by a oncologist prior to beginning the study&#xD;
&#xD;
          -  Participants should have the ability to understand and the willingness to sign a&#xD;
             written informed consent document&#xD;
&#xD;
          -  Participants must sign a study specific consent form prior to registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients have been diagnosed with other malignancy&#xD;
&#xD;
          -  Patients with uncontrolled intercurrent illness including, but not limited to, ongoing&#xD;
             or active infection or significant inflammation at treatment site or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements or whose&#xD;
             lab values do not meet the criteria above are excluded&#xD;
&#xD;
          -  Pregnant women are excluded from this study&#xD;
&#xD;
          -  Breast feeding women are excluded from this study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>18F-fluorothymidine</keyword>
  <keyword>18F-fluorodeoxyglucose</keyword>
  <keyword>Metastatic Breast Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT04411966
org study id: CMRPG2C0483
nct id: NCT04411966
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
We aim to investigate the value of 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) and
      18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT)
      for early prediction of treatment response and survival in patients with metastatic breast
      cancer after salvage therapy.
Patients with metastatic breast cancer were enrolled and received PET/CT using 18F-FLT and
      18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy. The
      standard reference for treatment response was classified according to Response Evaluation
      Criteria in Solid Tumors (RECIST) 1.1 criteria for contrast-enhanced CT (CE-CT) after 3
      months of systemic chemotherapy. The metabolic response on PET was assessed according to PET
      response criteria in solid tumors (PERCIST) criteria and was correlated to the treatment
      response, progression-free survival (PFS), and overall survival (OS).
intervention model: Sequential Assignment
intervention model description: Participant received 18F-FLT and 18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in 18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) maximal standardized uptake value (SUV) as response to therapy
time frame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
description: The response to therapy would be determined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) by contrast-enhanced computed tomography (CE-CT). The change of SUVmax between the responders and non responders on 18F-FLT and 18F-FDG would be compared.
measure: Compare Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) and European Organization for Research and Treatment of Cancer (EORCT) response by 18F-FLT-PET and 18F-FDG-PET for the prediction of anatomic treatment response
time frame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, , each cycle is 28 days)
description: We will use both EORTC and PERCIST criteria to compare the 18F-FLT-PET and 18F-FDG-PET metabolic response for the predictions of anatomic treatment response. Receiver operating characteristic (ROC) curve analysis and comparison were performed to evaluate the performance of 18F-FLT-PET and 18F-FDG-PET in predicting the anatomic treatment response, both with EORTC and PERCIST criteria.
measure: Progression-free survival (PFS) was defined as the time from the date of inclusion in the study to disease recurrence or progression.
time frame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
description: Compare Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) and European Organization for Research and Treatment of Cancer (EORCT) response by 18F-FLT-PET and 18F-FDG-PET for the prediction of survival outcomes
measure: Overall survival (OS) was defined as the time from the date of inclusion in the study to the date of death from any cause or last follow-up.
time frame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
description: Compare Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) and European Organization for Research and Treatment of Cancer (EORCT) response by 18F-FLT-PET and 18F-FDG-PET for the prediction of survival outcomes
arm group label: 18F-fluorothymidine PET
arm group type: Experimental
description: Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes at least 10 days prior to systemic chemotherapy, and at least 10 days after first and second cycles of systemic chemotherapy.
intervention type: Diagnostic Test
intervention name: 18F-fluorothymidine
description: Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes at least 10 days prior to systemic chemotherapy, and at least 10 days after first and second cycles of systemic chemotherapy.
arm group label: 18F-fluorothymidine PET
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Breast Neoplasms