<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/NCT03036943</url>
  </required_header>
  <id_info>
    <org_study_id>OCTO_078</org_study_id>
    <nct_id>NCT03036943</nct_id>
  </id_info>
  <brief_title>Fluciclovine (18F) Imaging of Breast Cancer</brief_title>
  <acronym>FRONTIER</acronym>
  <official_title>An Open-labelled Study to Characterise Fluciclovine (18F) Uptake Measured by positRon emissiON Tomography In Breast cancER</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Earth Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out what a new amino acid-based PET agent, fluciclovine&#xD;
      (18F), can tell us about breast cancer biology (how it grows and develops), and quantify the&#xD;
      differences in fluciclovine (18F) uptake between breast cancer subtypes. This will inform&#xD;
      further work to investigate its use in breast cancer management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">December 4, 2018</completion_date>
  <primary_completion_date type="Actual">December 4, 2018</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>Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging.</measure>
    <time_frame>From PET/CT scan commencing approx 30 seconds after fluciclovine (18F) administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amino acid transporter (AAT) and related growth pathway expression levels quantitatively assessed by immunohistochemistry using the H-score method, and correlated to fluciclovine (18F) uptake (SUV).</measure>
    <time_frame>From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumour metabolite levels characterized by fold change compared to metabolite levels in the adjacent normal tissue, and correlated to fluciclovine (18F) uptake.</measure>
    <time_frame>From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Fluciclovine (18F) PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Fluciclovine</intervention_name>
    <description>Fluciclovine (18F) PET/CT scan completed &gt;= 48 hours prior to surgical resection for breast cancer</description>
    <arm_group_label>Fluciclovine (18F) PET/CT</arm_group_label>
    <other_name>18F</other_name>
    <other_name>FACBC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Biopsy proven breast cancer (invasive ductal or ductal carcinoma in situ (DCIS))&#xD;
             measuring ≥ 1.5cm&#xD;
&#xD;
               -  Tumour size should be based on the longest diameter measured on ultrasound,&#xD;
                  mammogram or MRI performed within 2 months prior to enrolment.&#xD;
&#xD;
          2. No prior treatment for breast cancer.&#xD;
&#xD;
          3. Female, Age &gt;= 40 years.&#xD;
&#xD;
          4. The patient is willing and able to comply with the protocol scheduled visits and&#xD;
             examinations for the duration of the study. Women of childbearing potential must&#xD;
             follow contraception guidance given as standard of care at breast cancer diagnosis.&#xD;
&#xD;
          5. Written (signed and dated) informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or breastfeeding women&#xD;
&#xD;
          2. Major surgery or significant traumatic injury within four weeks prior to enrolment.&#xD;
&#xD;
          3. Treatment with any other investigational agent, or participation in another&#xD;
             interventional clinical study within 4 weeks prior to enrolment.&#xD;
&#xD;
          4. Multifocal breast cancer (defined as more than two tumours, either unilateral or&#xD;
             bilateral).&#xD;
&#xD;
          5. Known hypersensitivity to fluciclovine (18F) or any of its constituents.&#xD;
&#xD;
          6. Other psychological, social or medical condition, physical examination finding or a&#xD;
             laboratory abnormality that the Investigator considers would make the patient a poor&#xD;
             study candidate or could interfere with protocol compliance or the interpretation of&#xD;
             study results.&#xD;
&#xD;
          7. Any other active malignancy or any previous diagnosis of melanoma.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrian Harris, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</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>
  <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/NCT03036943
org study id: OCTO_078
nct id: NCT03036943
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find out what a new amino acid-based PET agent, fluciclovine
      (18F), can tell us about breast cancer biology (how it grows and develops), and quantify the
      differences in fluciclovine (18F) uptake between breast cancer subtypes. This will inform
      further work to investigate its use in breast cancer management.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging.
time frame: From PET/CT scan commencing approx 30 seconds after fluciclovine (18F) administration
measure: Amino acid transporter (AAT) and related growth pathway expression levels quantitatively assessed by immunohistochemistry using the H-score method, and correlated to fluciclovine (18F) uptake (SUV).
time frame: From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan
measure: Tumour metabolite levels characterized by fold change compared to metabolite levels in the adjacent normal tissue, and correlated to fluciclovine (18F) uptake.
time frame: From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan
arm group label: Fluciclovine (18F) PET/CT
arm group type: Experimental
intervention type: Radiation
intervention name: Fluciclovine
description: Fluciclovine (18F) PET/CT scan completed >= 48 hours prior to surgical resection for breast cancer
arm group label: Fluciclovine (18F) PET/CT
other name: 18F
other name: FACBC
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Adrian Harris, Prof
role: Principal Investigator
affiliation: University of Oxford
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided