<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/NCT01712815</url>
  </required_header>
  <id_info>
    <org_study_id>1B-11-9</org_study_id>
    <secondary_id>NCI-2012-02041</secondary_id>
    <nct_id>NCT01712815</nct_id>
  </id_info>
  <brief_title>PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer</brief_title>
  <official_title>Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects of positron emission tomography (PET)/computed&#xD;
      tomography (CT) in evaluating response to chemotherapy in patients with breast cancer.&#xD;
      Comparing results of diagnostic procedures done before, during, and after chemotherapy may&#xD;
      help doctors predict a patient's response to treatment and help plan the best treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES: I. Study fludeoxyglucose [18F]&#xD;
      2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine (FMAU) (fluorine F 18-clevudine&#xD;
      ) in 10 patients with known breast cancer to obtain data on safety, circulating metabolite,&#xD;
      tumor imaging feasibility, and radiation dosimetry. II. Assess the potential utility of&#xD;
      FMAU-PET in the imaging evaluation of chemotherapeutic response in 15 patients with breast&#xD;
      cancer. OUTLINE: Patients receive fluorine F18-clevudine intravenously (IV) over 1 minute and&#xD;
      then undergo PET/CT scan at baseline. Patients with human epidermal growth factor receptor 2&#xD;
      positive (HER2+) breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks&#xD;
      after the first course of treatment and after completion of treatment. After completion of&#xD;
      study treatment, patients are followed up at 24 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient accrual&#xD;
  </why_stopped>
  <start_date type="Actual">November 22, 2013</start_date>
  <completion_date type="Actual">November 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 24 hours after completion of study treatment</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>HER2-positive Breast Cancer</condition>
  <condition>Recurrent Breast Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Stage II Breast Cancer</condition>
  <condition>Stage IIIA Breast Cancer</condition>
  <condition>Stage IIIB Breast Cancer</condition>
  <condition>Stage IIIC Breast Cancer</condition>
  <condition>Stage IV Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Diagnostic (fluorine F 18-clevudine PET/CT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive fluorine F18-clevudine IV over 1 minute and then undergo PET/CT scan at baseline. Patients with HER2+ breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks after the first course of treatment and after completion of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Diagnostic (fluorine F 18-clevudine PET/CT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pharmacological study</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Diagnostic (fluorine F 18-clevudine PET/CT)</arm_group_label>
    <other_name>pharmacological studies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Diagnostic (fluorine F 18-clevudine PET/CT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>fluorine F 18-clevudine</intervention_name>
    <description>Undergo fluorine F 18-clevudine PET/CT scan</description>
    <arm_group_label>Diagnostic (fluorine F 18-clevudine PET/CT)</arm_group_label>
    <other_name>18F-2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine</other_name>
    <other_name>18F-FMAU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>positron emission tomography/computed tomography</intervention_name>
    <description>Undergo fluorine F18-clevudine PET/CT scan</description>
    <arm_group_label>Diagnostic (fluorine F 18-clevudine PET/CT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for Aim 1:&#xD;
&#xD;
          -  Scheduled to receive therapy with trastuzumab plus chemotherapy as part of standard&#xD;
             care&#xD;
&#xD;
          -  Have one or more breast tumors visualized by conventional PET/CT, CT or magnetic&#xD;
             resonance imaging (MRI) prior to the PET FMAU study; PET/CT should be within a week&#xD;
             prior to 18-F FMAU&#xD;
&#xD;
        Inclusion criteria for Aim 2:&#xD;
&#xD;
          -  Have been diagnosed with a HER2+ invasive cancer of the breast&#xD;
&#xD;
          -  Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part&#xD;
             of standard care&#xD;
&#xD;
          -  Have one or more breast tumors visualized by conventional PET/CT, CT or MRI prior to&#xD;
             the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have undergone chemotherapy or radiation therapy within the previous one month&#xD;
&#xD;
          -  Women of childbearing potential, unless they have had a negative urine human chorionic&#xD;
             gonadotropin (HCG) within the previous 24 hours of the procedure&#xD;
&#xD;
          -  Patients who have had surgery at the site of the suspected lesion within 1 month&#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>Peter Conti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Clevudine</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/NCT01712815
org study id: 1B-11-9
secondary id: NCI-2012-02041
nct id: NCT01712815
lead sponsor: 
collaborator: 
has dmc: Yes
This phase I trial studies the side effects of positron emission tomography (PET)/computed
      tomography (CT) in evaluating response to chemotherapy in patients with breast cancer.
      Comparing results of diagnostic procedures done before, during, and after chemotherapy may
      help doctors predict a patient's response to treatment and help plan the best treatment.
PRIMARY OBJECTIVES: I. Study fludeoxyglucose [18F]
      2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine (FMAU) (fluorine F 18-clevudine
      ) in 10 patients with known breast cancer to obtain data on safety, circulating metabolite,
      tumor imaging feasibility, and radiation dosimetry. II. Assess the potential utility of
      FMAU-PET in the imaging evaluation of chemotherapeutic response in 15 patients with breast
      cancer. OUTLINE: Patients receive fluorine F18-clevudine intravenously (IV) over 1 minute and
      then undergo PET/CT scan at baseline. Patients with human epidermal growth factor receptor 2
      positive (HER2+) breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks
      after the first course of treatment and after completion of treatment. After completion of
      study treatment, patients are followed up at 24 hours.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy
time frame: Up to 1 year
measure: Incidence of adverse events
time frame: Up to 24 hours after completion of study treatment
arm group label: Diagnostic (fluorine F 18-clevudine PET/CT)
arm group type: Experimental
description: Patients receive fluorine F18-clevudine IV over 1 minute and then undergo PET/CT scan at baseline. Patients with HER2+ breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks after the first course of treatment and after completion of treatment.
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Diagnostic (fluorine F 18-clevudine PET/CT)
intervention type: Other
intervention name: pharmacological study
description: Correlative studies
arm group label: Diagnostic (fluorine F 18-clevudine PET/CT)
other name: pharmacological studies
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Diagnostic (fluorine F 18-clevudine PET/CT)
intervention type: Radiation
intervention name: fluorine F 18-clevudine
description: Undergo fluorine F 18-clevudine PET/CT scan
arm group label: Diagnostic (fluorine F 18-clevudine PET/CT)
other name: 18F-2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine
other name: 18F-FMAU
intervention type: Procedure
intervention name: positron emission tomography/computed tomography
description: Undergo fluorine F18-clevudine PET/CT scan
arm group label: Diagnostic (fluorine F 18-clevudine PET/CT)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Conti, MD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Clevudine