<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/NCT02193672</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0591</org_study_id>
    <nct_id>NCT02193672</nct_id>
  </id_info>
  <brief_title>A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide to Correlate With Response to Anti-Cancer Therapy</brief_title>
  <official_title>A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide to Correlate With Response to Anti-Cancer Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to find out if using the tracer (liquid used in&#xD;
      imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography&#xD;
      (PET/CT) scans will help researchers learn more quickly if the disease is responding to&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PET/CT Scans:&#xD;
&#xD;
      If you are found eligible to take part in this study, you will have a PET/CT scan at your&#xD;
      treatment baseline visit, about 1 week before your first cycle of chemotherapy. You will then&#xD;
      have a second PET/CT scan at the end of your first cycle of chemotherapy (about 3-4 weeks&#xD;
      after starting chemotherapy).&#xD;
&#xD;
      For up to 6 hours before the PET/CT scan, you must not eat or drink anything except water. A&#xD;
      small needle and tube will be placed in your arm, and you will receive an injection of a very&#xD;
      small amount of a mildly radioactive material into your bloodstream (the investigational&#xD;
      tracer, [18F]fluciclatide). The radioactive nature of this injected material allows the&#xD;
      scanner to &quot;see&quot; it in certain places in your body. After the injection, you will need to&#xD;
      rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared&#xD;
      to wait for between 45 and 90 minutes. During the scan, you will lie flat on your back on a&#xD;
      table. The scan itself may last up to 1 hour.&#xD;
&#xD;
      Each PET/CT imaging session will last about 4 hours total from the time you arrive at the&#xD;
      clinic until you are discharged and allowed to go home. You may be discharged 30 minutes&#xD;
      after the scan is complete, if the doctor thinks you are clinically stable and it is safe for&#xD;
      you to leave.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      If the following tests are already being performed as part of the clinical research study you&#xD;
      are participating in or as part of standard care, they will not need to be repeated for this&#xD;
      study.&#xD;
&#xD;
      Baseline Visit (before the first PET/CT is performed):&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 3 tablespoons) will be drawn for routine tests.&#xD;
&#xD;
        -  If you can become pregnant, urine will be collected for a pregnancy test. To take part&#xD;
           in this study, you must not be pregnant.&#xD;
&#xD;
      End of Cycle 1 (before the second PET/CT is performed):&#xD;
&#xD;
      -Blood (about 3 tablespoons) will be drawn for routine tests.&#xD;
&#xD;
      About 24 hours after each PET/CT is performed, the study staff will call you by telephone to&#xD;
      ask about your health status and any side effects you may be experiencing.&#xD;
&#xD;
      Anytime within the next month after the second PET/CT scan, blood (about 3 tablespoons) will&#xD;
      be drawn for routine tests.&#xD;
&#xD;
      When your chemotherapy is over, you will have a third PET/CT scan as part of your standard&#xD;
      care, and an FDG tracer will be used for that scan.&#xD;
&#xD;
      Length of Participation:&#xD;
&#xD;
      Your study participation will end about 6 weeks after your second PET/CT scan is performed.&#xD;
&#xD;
      This is an investigational study. [18F]Fluciclatide is not FDA approved or commercially&#xD;
      available. At this time, it is only being used in research.&#xD;
&#xD;
      Up to 50 patients will take part in this research study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <phase>Phase 1</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 in Tumor Uptake</measure>
    <time_frame>After 2, four week chemotherapy cycles</time_frame>
    <description>Primary efficacy endpoint is change in tumor uptake of investigational agent [18F]Fluciclatide, as measured by standardized uptake value (SUVFluciclatide) from before treatment to after one cycle of treatment but before the second cycle starts. This determined from investigational agent [18F]Fluciclatide PET scans. Changes in SUVFluciclatide compared to standard tumor's response measured after completion of 2 cycles of treatment as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) as well as tumor size change as a continuous variable measured by the standard CT or PET/CT scans. Tumor size can also be measured by the WHO two-dimensional measurement in addition to the Response Evaluation Criteria in Solid Tumors (RECIST), one-dimensional measurement. Changes in SUVFluciclatide after one cycle also compared to tumor volume and tumor size as continuous variables after two cycles.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Advanced Cancers</condition>
  <arm_group>
    <arm_group_label>PET/CT + [18F]Fluciclatide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At baseline: Participants have PET/CT imaging within 7 days prior to initiation of chemotherapy treatment. Participants monitored at 24 hours post scan via telephone.&#xD;
On treatment: Participants have PET/CT imaging at end of the first cycle and prior to the initiation of the second cycle of chemotherapy. Participants assessed at 24 hours post scan via telephone call.&#xD;
Baseline and on treatment PET/CT imaging performed with agent [18F] Fluciclatide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F] Fluciclatide</intervention_name>
    <description>[18F] Fluciclatide given by vein before PET/CT scan.</description>
    <arm_group_label>PET/CT + [18F]Fluciclatide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PET/CT Scan</intervention_name>
    <description>PET/CT scan performed at treatment baseline visit, and about 1 week before first cycle of chemotherapy. Then, a PET/CT scan performed at end of first cycle of chemotherapy.</description>
    <arm_group_label>PET/CT + [18F]Fluciclatide</arm_group_label>
    <other_name>Positron emission tomography / computed tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phone Calls</intervention_name>
    <description>Phone call to participants by study staff about 24 hours after each PET/CT is performed.</description>
    <arm_group_label>PET/CT + [18F]Fluciclatide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is &gt;/= 18 years and male or female of any race/ethnicity.&#xD;
&#xD;
          2. Patient or patient's legally authorized representative provides written informed&#xD;
             consent and is willing to comply with protocol requirements.&#xD;
&#xD;
          3. Patient must be scheduled to receive an anti-VEGF inhibitor (bevacizumab, sorafenib,&#xD;
             sunitinib, other), mTOR inhibitor (temsirolimus, everolimus, other), or other&#xD;
             molecules with antiangiogenic properties including taxol as anti-cancer therapy.&#xD;
&#xD;
          4. Patient must have normal hepatic and renal function defined as: 1) AST (SGOT)/ALT&#xD;
             (SGPT) &lt;/=3 x institutional upper limit of normal and 2) serum creatinine &lt;/= 2x&#xD;
             institutional upper limit of normal.&#xD;
&#xD;
          5. Platelet count of &gt; 75 x 10^3/μL&#xD;
&#xD;
          6. Patients may participate in clinical trials in the Phase I program.&#xD;
&#xD;
          7. Patients with any solid tumor type.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is not capable of complying with study procedures.&#xD;
&#xD;
          2. Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of&#xD;
             the following: 1) Confirming in medical history that the patient is postmenopausal&#xD;
             defined as 12 consecutive months of amenorrhea, or surgically sterile, 2) Confirming&#xD;
             the patient is using one of the following methods of birth control for a minimum of&#xD;
             one month prior to entry into this study: Intrauterine device (IUD), oral&#xD;
             contraceptives, Depo-Provera, or Norplant, 3) Confirming a negative urine dipstick&#xD;
             test taken the morning of receiving the investigational agent [18F]fluciclatide.&#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>Apostolia M. Tsimberidou, MD,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced cancers</keyword>
  <keyword>PET/CT</keyword>
  <keyword>Positron emission tomography / computed tomography</keyword>
  <keyword>[18F]Fluciclatide</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Phone calls</keyword>
  <!-- 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/NCT02193672
org study id: 2013-0591
nct id: NCT02193672
lead sponsor: 
collaborator: 
has dmc: No
The goal of this clinical research study is to find out if using the tracer (liquid used in
      imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography
      (PET/CT) scans will help researchers learn more quickly if the disease is responding to
      treatment.
PET/CT Scans:

      If you are found eligible to take part in this study, you will have a PET/CT scan at your
      treatment baseline visit, about 1 week before your first cycle of chemotherapy. You will then
      have a second PET/CT scan at the end of your first cycle of chemotherapy (about 3-4 weeks
      after starting chemotherapy).

      For up to 6 hours before the PET/CT scan, you must not eat or drink anything except water. A
      small needle and tube will be placed in your arm, and you will receive an injection of a very
      small amount of a mildly radioactive material into your bloodstream (the investigational
      tracer, [18F]fluciclatide). The radioactive nature of this injected material allows the
      scanner to "see" it in certain places in your body. After the injection, you will need to
      rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared
      to wait for between 45 and 90 minutes. During the scan, you will lie flat on your back on a
      table. The scan itself may last up to 1 hour.

      Each PET/CT imaging session will last about 4 hours total from the time you arrive at the
      clinic until you are discharged and allowed to go home. You may be discharged 30 minutes
      after the scan is complete, if the doctor thinks you are clinically stable and it is safe for
      you to leave.

      Study Visits:

      If the following tests are already being performed as part of the clinical research study you
      are participating in or as part of standard care, they will not need to be repeated for this
      study.

      Baseline Visit (before the first PET/CT is performed):

        -  You will have a physical exam.

        -  Blood (about 3 tablespoons) will be drawn for routine tests.

        -  If you can become pregnant, urine will be collected for a pregnancy test. To take part
           in this study, you must not be pregnant.

      End of Cycle 1 (before the second PET/CT is performed):

      -Blood (about 3 tablespoons) will be drawn for routine tests.

      About 24 hours after each PET/CT is performed, the study staff will call you by telephone to
      ask about your health status and any side effects you may be experiencing.

      Anytime within the next month after the second PET/CT scan, blood (about 3 tablespoons) will
      be drawn for routine tests.

      When your chemotherapy is over, you will have a third PET/CT scan as part of your standard
      care, and an FDG tracer will be used for that scan.

      Length of Participation:

      Your study participation will end about 6 weeks after your second PET/CT scan is performed.

      This is an investigational study. [18F]Fluciclatide is not FDA approved or commercially
      available. At this time, it is only being used in research.

      Up to 50 patients will take part in this research study. All will be enrolled at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in Tumor Uptake
time frame: After 2, four week chemotherapy cycles
description: Primary efficacy endpoint is change in tumor uptake of investigational agent [18F]Fluciclatide, as measured by standardized uptake value (SUVFluciclatide) from before treatment to after one cycle of treatment but before the second cycle starts. This determined from investigational agent [18F]Fluciclatide PET scans. Changes in SUVFluciclatide compared to standard tumor's response measured after completion of 2 cycles of treatment as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) as well as tumor size change as a continuous variable measured by the standard CT or PET/CT scans. Tumor size can also be measured by the WHO two-dimensional measurement in addition to the Response Evaluation Criteria in Solid Tumors (RECIST), one-dimensional measurement. Changes in SUVFluciclatide after one cycle also compared to tumor volume and tumor size as continuous variables after two cycles.
arm group label: PET/CT + [18F]Fluciclatide
arm group type: Experimental
description: At baseline: Participants have PET/CT imaging within 7 days prior to initiation of chemotherapy treatment. Participants monitored at 24 hours post scan via telephone.
On treatment: Participants have PET/CT imaging at end of the first cycle and prior to the initiation of the second cycle of chemotherapy. Participants assessed at 24 hours post scan via telephone call.
Baseline and on treatment PET/CT imaging performed with agent [18F] Fluciclatide.
intervention type: Drug
intervention name: [18F] Fluciclatide
description: [18F] Fluciclatide given by vein before PET/CT scan.
arm group label: PET/CT + [18F]Fluciclatide
intervention type: Procedure
intervention name: PET/CT Scan
description: PET/CT scan performed at treatment baseline visit, and about 1 week before first cycle of chemotherapy. Then, a PET/CT scan performed at end of first cycle of chemotherapy.
arm group label: PET/CT + [18F]Fluciclatide
other name: Positron emission tomography / computed tomography
intervention type: Behavioral
intervention name: Phone Calls
description: Phone call to participants by study staff about 24 hours after each PET/CT is performed.
arm group label: PET/CT + [18F]Fluciclatide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Apostolia M. Tsimberidou, MD,PHD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor