<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/NCT04410133</url>
  </required_header>
  <id_info>
    <org_study_id>BED-FLC-312</org_study_id>
    <nct_id>NCT04410133</nct_id>
  </id_info>
  <brief_title>Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases</brief_title>
  <acronym>REVELATE</acronym>
  <official_title>An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Blue Earth Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Precision For Medicine</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Blue Earth Diagnostics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish&#xD;
      the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in&#xD;
      detecting recurrent brain metastases after radiation therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2020</start_date>
  <completion_date type="Actual">June 5, 2023</completion_date>
  <primary_completion_date type="Actual">June 5, 2023</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Positron Emission Tomography (PET) Imaging study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases</measure>
    <time_frame>6 months</time_frame>
    <description>PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases</measure>
    <time_frame>6 months</time_frame>
    <description>NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases</measure>
    <time_frame>6 months</time_frame>
    <description>Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases</measure>
    <time_frame>6 months</time_frame>
    <description>Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-emergent adverse events</measure>
    <time_frame>48 hours</time_frame>
    <description>Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 2 days post-18F-fluciclovine administration.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Brain Metastases</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous administration of 18F fluciclovine for PET Scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F fluciclovine</intervention_name>
    <description>18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus</description>
    <arm_group_label>Patients</arm_group_label>
    <other_name>Axumin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is&#xD;
             an acute deterioration&#xD;
&#xD;
          2. Previous history of solid tumor brain metastasis of any origin&#xD;
&#xD;
          3. Histopathological confirmation of the primary solid tumor or a metastatic site within&#xD;
             4 years&#xD;
&#xD;
          4. Previous radiation therapy of brain metastatic lesion(s)&#xD;
&#xD;
          5. A reference lesion considered by the site investigator to be equivocal for recurrent&#xD;
             brain metastasis&#xD;
&#xD;
          6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI&#xD;
             findings and is planned for biopsy/neurosurgical intervention as standard of care&#xD;
             (SoC) or clinical follow-up as SoC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patients with a history of active hematological malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Hospital and Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Wayne Cancer Institute at Providence St. John's Health Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute at Baptist Health, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Georgia, Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Rogel Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine-Center for Clinical Imaging Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Quantitative Cancer Imaging at Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virgina University Cancer Institute</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Recurrent Brain Metastases</keyword>
  <keyword>Diagnostic</keyword>
  <keyword>Positron Emission Tomography (PET) Scan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Brain 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/NCT04410133
org study id: BED-FLC-312
nct id: NCT04410133
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish
      the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in
      detecting recurrent brain metastases after radiation therapy
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Positron Emission Tomography (PET) Imaging study
primary purpose: Diagnostic
masking: None (Open Label)
measure: Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
time frame: 6 months
description: PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
measure: Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
time frame: 6 months
description: NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
measure: Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
time frame: 6 months
description: Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
measure: Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
time frame: 6 months
description: Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
measure: Treatment-emergent adverse events
time frame: 48 hours
description: Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 2 days post-18F-fluciclovine administration.
arm group label: Patients
arm group type: Experimental
description: Single intravenous administration of 18F fluciclovine for PET Scan
intervention type: Drug
intervention name: 18F fluciclovine
description: 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
arm group label: Patients
other name: Axumin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms
sharing ipd: Undecided