<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/NCT03242824</url>
  </required_header>
  <id_info>
    <org_study_id>16-006072</org_study_id>
    <secondary_id>MC167B</secondary_id>
    <secondary_id>NCI-2017-02479</secondary_id>
    <nct_id>NCT03242824</nct_id>
  </id_info>
  <brief_title>The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma</brief_title>
  <official_title>MC167B: Pilot Study Investigating the Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast&#xD;
      enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with&#xD;
      target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">June 16, 2021</completion_date>
  <primary_completion_date type="Actual">June 16, 2020</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants With Progression-free Survival</measure>
    <time_frame>up to 3 months</time_frame>
    <description>measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. Diagnosis date occurs prior to randomization by up to 15 years</time_frame>
    <description>Overall survival from initial diagnosis: Time from initial diagnosis to death from any cause censoring patients alive at their last follow-up, assessed up to 2 years from date of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities</measure>
    <time_frame>up to 2 years</time_frame>
    <description>The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Brief Fatigue Index (BFI) Change From Baseline</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Measured by change from baseline to 3 month evaluation in MDA-BFI global fatigue score. Brief fatigue index is a QOL questionnaire with scores ranging from 0, no fatigue, to 10, as bad as you can imagine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operative Count</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Count of patients that receive re-operation post re-irradiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life MDASI-BT Change From Baseline</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>QOL will be evaluated using the MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) and fatigue will be evaluated using the MD Anderson Brief Fatigue Inventory.Measured by change from baseline to 3 month evaluation in MDASI-BT overall symptom distress score. Scores may range from 0 to 10, with 0 being 'Not present' and 10 being 'As bad as imaginable'.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Glioma</condition>
  <arm_group>
    <arm_group_label>18F-DOPA PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 18FDOPA-PET for radiation treatment planning</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorine F 18 Fluorodopa</intervention_name>
    <description>Contrast used in PET</description>
    <arm_group_label>18F-DOPA PET</arm_group_label>
    <other_name>18F- FDOPA</other_name>
    <other_name>3,4-dihydroxy-6-[18F] fluoro-L-phenylalanine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-Modulated Radiation Therapy</intervention_name>
    <description>Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor</description>
    <arm_group_label>18F-DOPA PET</arm_group_label>
    <other_name>IMRT</other_name>
    <other_name>Intensity Modulated RT</other_name>
    <other_name>Intensity-Modulated Radiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>imaging test</description>
    <arm_group_label>18F-DOPA PET</arm_group_label>
    <other_name>PET</other_name>
    <other_name>PET SCAN</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age &gt; or equal to 18 years&#xD;
&#xD;
          -  ECOG PS &lt; or equal to 3&#xD;
&#xD;
          -  Histologically confirmed or radiographic evidence of recurrent/progressive glioma.&#xD;
&#xD;
          -  History of radiation therapy to the brain for prior diagnosis of glioma&#xD;
&#xD;
          -  Planned radiation treatments at Mayo Clinic Rochester&#xD;
&#xD;
          -  Provide informed written consent&#xD;
&#xD;
          -  Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry&#xD;
             and Biobanking study, IRB number 15-000136 (blood draw optional)&#xD;
&#xD;
          -  Willing to return to enrolling institution for follow-up during Active Monitoring&#xD;
             Phase of the study.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  More than one prior course of radiotherapy or prior prescription doses exceeding 60 Gy&#xD;
             to re-irradiation target volumes&#xD;
&#xD;
          -  Unable to undergo MRI scans with contrast&#xD;
&#xD;
          -  Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking anti&#xD;
             dopaminergic, or dopamine agonist medication or less than 6 half-lives from&#xD;
             discontinuance of dopamine agonists.)&#xD;
&#xD;
        Note: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion,&#xD;
        buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine,&#xD;
        phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline). If a patient is&#xD;
        on any of these drugs, list which ones on the On-Study form.&#xD;
&#xD;
        -Any of the following:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Nursing women&#xD;
&#xD;
          -  Men or women of childbearing potential who are unwilling to employ adequate&#xD;
             contraception&#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>Nadia N Laack</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>September 23, 2021</results_first_submitted>
  <results_first_submitted_qc>June 30, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 5, 2022</results_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 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>Glioma</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03242824/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>1 registered patient did not proceed to protocol treatment because they were deemed ineligible.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>18F-DOPA PET</title>
          <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>18F-DOPA PET</title>
          <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" lower_limit="38" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants With Progression-free Survival</title>
        <description>measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls</description>
        <time_frame>up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>18F-DOPA PET</title>
            <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Progression-free Survival</title>
          <description>measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls</description>
          <units>Proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" lower_limit="0.632" upper_limit="0.958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival from initial diagnosis: Time from initial diagnosis to death from any cause censoring patients alive at their last follow-up, assessed up to 2 years from date of randomization</description>
        <time_frame>From date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. Diagnosis date occurs prior to randomization by up to 15 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>18F-DOPA PET</title>
            <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival from initial diagnosis: Time from initial diagnosis to death from any cause censoring patients alive at their last follow-up, assessed up to 2 years from date of randomization</description>
          <units>years</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="2.4" upper_limit="NA">Upper limit on 95% confidence interval is not estimable (NE), due to an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities</title>
        <description>The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)</description>
        <time_frame>up to 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>18F-DOPA PET</title>
            <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
          </group>
        </group_list>
        <measure>
          <title>Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities</title>
          <description>The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Brief Fatigue Index (BFI) Change From Baseline</title>
        <description>Measured by change from baseline to 3 month evaluation in MDA-BFI global fatigue score. Brief fatigue index is a QOL questionnaire with scores ranging from 0, no fatigue, to 10, as bad as you can imagine.</description>
        <time_frame>Baseline and 3 months</time_frame>
        <population>All patients that entered a baseline and at 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>18F-DOPA PET</title>
            <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Brief Fatigue Index (BFI) Change From Baseline</title>
          <description>Measured by change from baseline to 3 month evaluation in MDA-BFI global fatigue score. Brief fatigue index is a QOL questionnaire with scores ranging from 0, no fatigue, to 10, as bad as you can imagine.</description>
          <population>All patients that entered a baseline and at 3 months.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" lower_limit="-0.75" upper_limit="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Re-operative Count</title>
        <description>Count of patients that receive re-operation post re-irradiation</description>
        <time_frame>up to 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>18F-DOPA PET</title>
            <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
          </group>
        </group_list>
        <measure>
          <title>Re-operative Count</title>
          <description>Count of patients that receive re-operation post re-irradiation</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life MDASI-BT Change From Baseline</title>
        <description>QOL will be evaluated using the MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) and fatigue will be evaluated using the MD Anderson Brief Fatigue Inventory.Measured by change from baseline to 3 month evaluation in MDASI-BT overall symptom distress score. Scores may range from 0 to 10, with 0 being 'Not present' and 10 being 'As bad as imaginable'.</description>
        <time_frame>Baseline and 3 months</time_frame>
        <population>All treated patients that had available data at baseline and during end of treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>18F-DOPA PET</title>
            <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life MDASI-BT Change From Baseline</title>
          <description>QOL will be evaluated using the MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) and fatigue will be evaluated using the MD Anderson Brief Fatigue Inventory.Measured by change from baseline to 3 month evaluation in MDASI-BT overall symptom distress score. Scores may range from 0 to 10, with 0 being 'Not present' and 10 being 'As bad as imaginable'.</description>
          <population>All treated patients that had available data at baseline and during end of treatment.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" lower_limit="-0.84" upper_limit="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 2 years from randomization</time_frame>
      <desc>The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:&#xD;
(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)</desc>
      <group_list>
        <group group_id="E1">
          <title>18F-DOPA PET</title>
          <description>Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 12</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Eye disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Optic nerve disorder</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="49" subjects_affected="17" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dermatitis radiation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle weakness lower limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Central nervous system necrosis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="7" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cognitive disturbance</sub_title>
                <counts group_id="E1" events="23" subjects_affected="12" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dysphasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle weakness left-sided</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle weakness right-sided</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nadia N. Laack, MD, MS</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507/284-2511</phone>
      <email>Laack.Nadia@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03242824
org study id: 16-006072
secondary id: MC167B
secondary id: NCI-2017-02479
nct id: NCT03242824
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast
      enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with
      target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of Participants With Progression-free Survival
time frame: up to 3 months
description: measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls
measure: Overall Survival
time frame: From date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. Diagnosis date occurs prior to randomization by up to 15 years
description: Overall survival from initial diagnosis: Time from initial diagnosis to death from any cause censoring patients alive at their last follow-up, assessed up to 2 years from date of randomization
measure: Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities
time frame: up to 2 years
description: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)
measure: Quality of Life Brief Fatigue Index (BFI) Change From Baseline
time frame: Baseline and 3 months
description: Measured by change from baseline to 3 month evaluation in MDA-BFI global fatigue score. Brief fatigue index is a QOL questionnaire with scores ranging from 0, no fatigue, to 10, as bad as you can imagine.
measure: Re-operative Count
time frame: up to 2 years
description: Count of patients that receive re-operation post re-irradiation
measure: Quality of Life MDASI-BT Change From Baseline
time frame: Baseline and 3 months
description: QOL will be evaluated using the MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) and fatigue will be evaluated using the MD Anderson Brief Fatigue Inventory.Measured by change from baseline to 3 month evaluation in MDASI-BT overall symptom distress score. Scores may range from 0 to 10, with 0 being 'Not present' and 10 being 'As bad as imaginable'.
arm group label: 18F-DOPA PET
arm group type: Experimental
description: Patients will receive 18FDOPA-PET for radiation treatment planning
intervention type: Drug
intervention name: Fluorine F 18 Fluorodopa
description: Contrast used in PET
arm group label: 18F-DOPA PET
other name: 18F- FDOPA
other name: 3,4-dihydroxy-6-[18F] fluoro-L-phenylalanine
intervention type: Radiation
intervention name: Intensity-Modulated Radiation Therapy
description: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor
arm group label: 18F-DOPA PET
other name: IMRT
other name: Intensity Modulated RT
other name: Intensity-Modulated Radiotherapy
intervention type: Procedure
intervention name: Positron Emission Tomography
description: imaging test
arm group label: 18F-DOPA PET
other name: PET
other name: PET SCAN
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nadia N Laack
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioma
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 