<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/NCT02236546</url>
  </required_header>
  <id_info>
    <org_study_id>VICC MEL 1372</org_study_id>
    <secondary_id>NCI-2014-00179</secondary_id>
    <secondary_id>VICC MEL 1372</secondary_id>
    <secondary_id>P30CA068485</secondary_id>
    <nct_id>NCT02236546</nct_id>
  </id_info>
  <brief_title>FDG-PET in Advanced Melanoma</brief_title>
  <official_title>FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt-Ingram Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt-Ingram Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies how well FDG-PET/CT measures early response in patients with&#xD;
      stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography&#xD;
      (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, [18F]fluorodeoxyglucose&#xD;
      (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before,&#xD;
      during, and after treatment may improve methods for predicting which patients may benefit&#xD;
      from therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To correlate treatment-induced changes in FDG uptake with changes in tumor size and&#xD;
      progression-free survival (PFS) in patients receiving therapy for advanced melanoma.&#xD;
&#xD;
      II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or&#xD;
      expression of available molecular biomarkers from patients receiving therapy for advanced&#xD;
      melanoma.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion of&#xD;
      the first treatment course (day 21), and after completion of the fourth treatment course (day&#xD;
      84).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    loss of funding&#xD;
  </why_stopped>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST</measure>
    <time_frame>Baseline to the completion of 6 courses of treatment</time_frame>
    <description>The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response (OR)</measure>
    <time_frame>Day 84</time_frame>
    <description>The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years</time_frame>
    <description>Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation</measure>
    <time_frame>Baseline to day 21</time_frame>
    <description>The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Recurrent Melanoma</condition>
  <condition>Stage IIIA Melanoma</condition>
  <condition>Stage IIIB Melanoma</condition>
  <condition>Stage IIIC Melanoma</condition>
  <condition>Stage IV Melanoma</condition>
  <arm_group>
    <arm_group_label>FDG-PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>[18F]fluorodeoxyglucose</intervention_name>
    <description>FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.</description>
    <arm_group_label>FDG-PET/CT</arm_group_label>
    <other_name>18-F-deoxy-glucose</other_name>
    <other_name>18-F-deoxyglucose</other_name>
    <other_name>FDG</other_name>
    <other_name>fluorodeoxyglucose F-18</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Molecular assays on biopsied tissue</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>FDG-PET/CT</arm_group_label>
    <other_name>immunohistochemistry</other_name>
    <other_name>genetic assay</other_name>
    <other_name>laboratory biomarker analysis</other_name>
    <other_name>molecular profiling</other_name>
    <other_name>gene expression</other_name>
    <other_name>tissue microarray</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>positron emission tomography</intervention_name>
    <description>Undergo FDG-PET/CT</description>
    <arm_group_label>FDG-PET/CT</arm_group_label>
    <other_name>PET</other_name>
    <other_name>PET scan</other_name>
    <other_name>tomography, emission computed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>computed tomography</intervention_name>
    <description>CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.</description>
    <arm_group_label>FDG-PET/CT</arm_group_label>
    <other_name>CT</other_name>
    <other_name>tomography, computed</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have signed Institutional Review Board (IRB)-approved informed consent&#xD;
             documentation&#xD;
&#xD;
          -  Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma&#xD;
             or stage III with bulky disease which may or may not be amenable for surgery and are&#xD;
             receiving therapy at present&#xD;
&#xD;
          -  Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer&#xD;
             Center (VICC) Melanoma Program; this will include patients receiving standard-of-care&#xD;
             chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to&#xD;
             VICC clinical trials for the study of investigational agents&#xD;
&#xD;
          -  Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per&#xD;
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with PET&#xD;
             Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at least&#xD;
             one lesion measuring at least 2 cm in the longest diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic&#xD;
             gonadotropin (HCG) will be performed on women of child bearing potential&#xD;
&#xD;
          -  Subjects who have experienced allergic or other adverse reactions in response to&#xD;
             intravenous injection of fluorinated radiotracers and other contrast media used in&#xD;
             PET/CT&#xD;
&#xD;
          -  Subjects incapable of giving informed written consent, for the following reasons:&#xD;
&#xD;
               -  Inability to adhere to the experimental protocols for any reason&#xD;
&#xD;
               -  Inability to communicate with the research team&#xD;
&#xD;
               -  Limited ability to give informed consent due to mental disability, altered mental&#xD;
                  status, confusion, or psychiatric disorders&#xD;
&#xD;
               -  Prisoners or other individuals deemed to be susceptible to coercion&#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>Tom Yankeelov, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt-Ingram Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt-Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <results_first_submitted>March 1, 2017</results_first_submitted>
  <results_first_submitted_qc>April 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2017</results_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
    <investigator_full_name>Thomas Yankeelov</investigator_full_name>
    <investigator_title>Ingram Professor of Cancer Research, Professor of Radiology and Radiological Sciences, Biomedical Engineering, Physics, and Cancer Biology, Director of Cancer Imaging Research</investigator_title>
  </responsible_party>
  <keyword>fluorodeoxyglucose</keyword>
  <keyword>FDG</keyword>
  <keyword>PET/CT</keyword>
  <keyword>melanoma</keyword>
  <keyword>imaging biomarkers</keyword>
  <keyword>cancer imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deoxyglucose</mesh_term>
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited to this trial at Vanderbilt Medical Center in Nashville, TN from November 2014 to November 2015</recruitment_details>
      <pre_assignment_details>Four people consented to participate in this trial, one was determined to be ineligible.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FDG-PET/CT</title>
          <description>Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.&#xD;
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.&#xD;
Molecular assays on biopsied tissue: Correlative studies&#xD;
positron emission tomography: Undergo FDG-PET/CT&#xD;
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </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>FDG-PET/CT</title>
          <description>Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.&#xD;
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.&#xD;
Molecular assays on biopsied tissue: Correlative studies&#xD;
positron emission tomography: Undergo FDG-PET/CT&#xD;
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.66667" spread="19.85783"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST</title>
        <description>The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.</description>
        <time_frame>Baseline to the completion of 6 courses of treatment</time_frame>
        <population>Due to loss of funding data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>FDG-PET/CT</title>
            <description>Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.&#xD;
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.&#xD;
Molecular assays on biopsied tissue: Correlative studies&#xD;
positron emission tomography: Undergo FDG-PET/CT&#xD;
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST</title>
          <description>The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.</description>
          <population>Due to loss of funding data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response (OR)</title>
        <description>The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.</description>
        <time_frame>Day 84</time_frame>
        <population>Due to loss of funding data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>FDG-PET/CT</title>
            <description>Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.&#xD;
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.&#xD;
Molecular assays on biopsied tissue: Correlative studies&#xD;
positron emission tomography: Undergo FDG-PET/CT&#xD;
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response (OR)</title>
          <description>The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.</description>
          <population>Due to loss of funding data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS)</title>
        <description>Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.</description>
        <time_frame>Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years</time_frame>
        <population>Due to loss of funding data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>FDG-PET/CT</title>
            <description>Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.&#xD;
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.&#xD;
Molecular assays on biopsied tissue: Correlative studies&#xD;
positron emission tomography: Undergo FDG-PET/CT&#xD;
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS)</title>
          <description>Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.</description>
          <population>Due to loss of funding data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation</title>
        <description>The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.</description>
        <time_frame>Baseline to day 21</time_frame>
        <population>Due to loss of funding data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>FDG-PET/CT</title>
            <description>Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.&#xD;
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.&#xD;
Molecular assays on biopsied tissue: Correlative studies&#xD;
positron emission tomography: Undergo FDG-PET/CT&#xD;
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation</title>
          <description>The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.</description>
          <population>Due to loss of funding data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>FDG-PET/CT</title>
          <description>Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.&#xD;
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.&#xD;
Molecular assays on biopsied tissue: Correlative studies&#xD;
positron emission tomography: Undergo FDG-PET/CT&#xD;
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.</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="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </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>Dr. Tom Yankeelov</name_or_title>
      <organization>Vanderbilt-Ingram Cancer Center</organization>
      <email>thomas.yankeelov@utexas.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/NCT02236546
org study id: VICC MEL 1372
secondary id: NCI-2014-00179
secondary id: VICC MEL 1372
secondary id: P30CA068485
nct id: NCT02236546
lead sponsor: 
collaborator: 
has dmc: Yes
This clinical trial studies how well FDG-PET/CT measures early response in patients with
      stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography
      (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, [18F]fluorodeoxyglucose
      (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before,
      during, and after treatment may improve methods for predicting which patients may benefit
      from therapy.
PRIMARY OBJECTIVES:

      I. To correlate treatment-induced changes in FDG uptake with changes in tumor size and
      progression-free survival (PFS) in patients receiving therapy for advanced melanoma.

      II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or
      expression of available molecular biomarkers from patients receiving therapy for advanced
      melanoma.

      OUTLINE:

      Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion of
      the first treatment course (day 21), and after completion of the fourth treatment course (day
      84).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST
time frame: Baseline to the completion of 6 courses of treatment
description: The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.
measure: Objective Response (OR)
time frame: Day 84
description: The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.
measure: Progression-free Survival (PFS)
time frame: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years
description: Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.
measure: Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation
time frame: Baseline to day 21
description: The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.
arm group label: FDG-PET/CT
arm group type: Experimental
description: Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
intervention type: Diagnostic Test
intervention name: [18F]fluorodeoxyglucose
description: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
arm group label: FDG-PET/CT
other name: 18-F-deoxy-glucose
other name: 18-F-deoxyglucose
other name: FDG
other name: fluorodeoxyglucose F-18
intervention type: Other
intervention name: Molecular assays on biopsied tissue
description: Correlative studies
arm group label: FDG-PET/CT
other name: immunohistochemistry
other name: genetic assay
other name: laboratory biomarker analysis
other name: molecular profiling
other name: gene expression
other name: tissue microarray
intervention type: Device
intervention name: positron emission tomography
description: Undergo FDG-PET/CT
arm group label: FDG-PET/CT
other name: PET
other name: PET scan
other name: tomography, emission computed
intervention type: Device
intervention name: computed tomography
description: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.
arm group label: FDG-PET/CT
other name: CT
other name: tomography, computed
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tom Yankeelov, PhD
role: Principal Investigator
affiliation: Vanderbilt-Ingram Cancer Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt-Ingram Cancer Center
investigator full name: Thomas Yankeelov
investigator title: Ingram Professor of Cancer Research, Professor of Radiology and Radiological Sciences, Biomedical Engineering, Physics, and Cancer Biology, Director of Cancer Imaging Research
mesh term: Melanoma
mesh term: Deoxyglucose
mesh term: Fluorodeoxyglucose F18
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 