xml: <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/NCT06015295</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0159</org_study_id>
      <secondary_id>NCI-2023-06704</secondary_id>
      <nct_id>NCT06015295</nct_id>
    </id_info>
    <brief_title>A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy</brief_title>
    <official_title>A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>M.D. Anderson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Blue Earth Diagnostics</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>M.D. Anderson Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain&#xD;
        metastatic lesions in patients who are receiving immunotherapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objective:&#xD;
  &#xD;
          -  To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true-&#xD;
             versus pseudo-progression of brain metastatic lesions in patients on immunotherapy.&#xD;
  &#xD;
        Accuracy is defined as the number of concordant cases between Axumin PET-CT and the gold&#xD;
        standard truth divided by the total sample size.&#xD;
  &#xD;
        Secondary Objectives&#xD;
  &#xD;
          -  To assess diagnosis accuracy of Axumin PET-CT in detecting true- versus&#xD;
             pseudo-progression of brain metastatic lesions in patients on immunotherapy by&#xD;
             additional accuracy measures including sensitivity, specificity, negative predictive&#xD;
             value and positive predictive value.&#xD;
  &#xD;
          -  To evaluate the added clinical usefulness of Axumin PET-CT for imaging patients with&#xD;
             metastatic brain lesion(s).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 28, 2024</start_date>
    <completion_date type="Anticipated">March 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2025</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>Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0</measure>
      <time_frame>through study completion; an average of 1 year</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Brain Metastases</condition>
    <arm_group>
      <arm_group_label>18F-Fluciclovine (Axumin)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are expected to be in this research study for about 6-12 months. Participants will have up to 6 visits for screening tests, Axumin PET-CT scans, and information collection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>18F-Fluciclovine (Axumin)</intervention_name>
      <description>Given by Injection</description>
      <arm_group_label>18F-Fluciclovine (Axumin)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Pet Scan</intervention_name>
      <description>Scans</description>
      <arm_group_label>18F-Fluciclovine (Axumin)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years. Because no dosing or adverse event data are currently available on the&#xD;
               use of Axumin in pediatric patients, patients &lt;18 years of age are excluded from this&#xD;
               study.&#xD;
  &#xD;
            2. ECOG performance status ≤2 (Karnofsky ≥60%,).&#xD;
  &#xD;
            3. Willingness to participate in the study and ability to provide written informed&#xD;
               consent.&#xD;
  &#xD;
            4. Patients must have documented brain metastatic lesion(s) in the medical record.&#xD;
  &#xD;
            5. On active immunotherapy for the diagnosed malignancy. Concurrent other treatment is&#xD;
               allowed. Immunotherapy and other treatment regimens are determined by treating&#xD;
               physicians as per standard clinical practice.&#xD;
  &#xD;
            6. Patients with at least one metastatic brain lesion showing suspected pseudoprogression&#xD;
               on SoC imaging modality (such as CT, or MRI, or FDG PET-CT, or DOTATATE PET/CT, or&#xD;
               PSMA PET/CT).&#xD;
  &#xD;
            7. The suspected pseudoprogresson can be determined by imaging physician (such as&#xD;
               neuroradiologists and/or nuclear medicine physicians) and/or treating physicians&#xD;
               (usually are oncologists). Ideally, the target/index lesion should be measurable (at&#xD;
               discretion of investigator imaging physicians) and feasible for series follow up and&#xD;
               comparison at imaging physician's discretion.&#xD;
  &#xD;
            8. Ability and willingness to undergo another follow up Fluciclovine PET/CT, usually&#xD;
               within 60 days of SoC follow up imaging modality.&#xD;
  &#xD;
            9. Ability and willingness to undergo biopsy if needed per standard of care.&#xD;
  &#xD;
           10. Estimated life expectancy of at least 3 months as determined by the investigator or&#xD;
               treating physician.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or breastfeeding during participation in the study are excluded because:&#xD;
               There is no information on the risk of adverse developmental outcomes in pregnant&#xD;
               women or animals with the use of Fluciclovine F18. All radiopharmaceuticals, including&#xD;
               Axumin, have the potential to cause fetal harm depending on the fetal stage of&#xD;
               development and the magnitude of the radiation dose; There is no information on the&#xD;
               presence of Fluciclovine F18 in human milk, the effect on the breastfed infant, or the&#xD;
               effect on milk production.&#xD;
  &#xD;
            2. History of severe allergic reactions to Axumin PET radiopharmaceuticals. Mild to&#xD;
               moderate reactions that can be controlled by medications prior to the scheduled PET/CT&#xD;
               are acceptable.&#xD;
  &#xD;
            3. Patients with psychiatric illness/social situations that would limit compliance with&#xD;
               study requirements.&#xD;
  &#xD;
            4. Unable to lie flat during or tolerate PET-CT&#xD;
  &#xD;
            5. Contraindications to Axumin Injection have not been established in humans. None are&#xD;
               known or have been observed in nonclinical or clinical studies performed to date.&#xD;
  &#xD;
            6. Subjects with any medical condition or circumstance that the investigator believes may&#xD;
               compromise the safety or compliance of the subject to produce reliable data or&#xD;
               completing the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yang Lu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>M.D. Anderson Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yang Lu, MD</last_name>
      <phone>(713) 792-5768</phone>
      <email>ylu10@mdanderson.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>M D Anderson Cancer Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Yang Lu, MD</last_name>
        <phone>713-792-5768</phone>
        <email>ylu10@mdanderson.org</email>
      </contact>
      <investigator>
        <last_name>Yang Lu, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mdanderson.org</url>
      <description>M D Anderson Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 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>Neoplasm Metastasis</mesh_term>
      <mesh_term>Brain Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015295
  org study id: 2023-0159
  secondary id: NCI-2023-06704
  nct id: NCT06015295
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain
        metastatic lesions in patients who are receiving immunotherapy.
  Primary Objective:
  
          -  To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true-
             versus pseudo-progression of brain metastatic lesions in patients on immunotherapy.
  
        Accuracy is defined as the number of concordant cases between Axumin PET-CT and the gold
        standard truth divided by the total sample size.
  
        Secondary Objectives
  
          -  To assess diagnosis accuracy of Axumin PET-CT in detecting true- versus
             pseudo-progression of brain metastatic lesions in patients on immunotherapy by
             additional accuracy measures including sensitivity, specificity, negative predictive
             value and positive predictive value.
  
          -  To evaluate the added clinical usefulness of Axumin PET-CT for imaging patients with
             metastatic brain lesion(s).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
  time frame: through study completion; an average of 1 year
  arm group label: 18F-Fluciclovine (Axumin)
  arm group type: Experimental
  description: Participants are expected to be in this research study for about 6-12 months. Participants will have up to 6 visits for screening tests, Axumin PET-CT scans, and information collection.
  intervention type: Diagnostic Test
  intervention name: 18F-Fluciclovine (Axumin)
  description: Given by Injection
  arm group label: 18F-Fluciclovine (Axumin)
  intervention type: Diagnostic Test
  intervention name: Pet Scan
  description: Scans
  arm group label: 18F-Fluciclovine (Axumin)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yang Lu, MD
  role: Principal Investigator
  affiliation: M.D. Anderson Cancer Center
  last name: Yang Lu, MD
  phone: (713) 792-5768
  email: ylu10@mdanderson.org
  facility: 
  contact: 
  investigator: 
  country: United States
  url: http://www.mdanderson.org
  description: M D Anderson Cancer Center
  responsible party type: Sponsor
  mesh term: Neoplasm Metastasis
  mesh term: Brain Neoplasms