<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/NCT01666353</url>
  </required_header>
  <id_info>
    <org_study_id>J1208</org_study_id>
    <secondary_id>NA_00049919</secondary_id>
    <nct_id>NCT01666353</nct_id>
  </id_info>
  <brief_title>PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy</brief_title>
  <official_title>PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Melanoma Research Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to develop methods for quantitative imaging of solid tumors in patients who&#xD;
      are receiving immunotherapies that have a delayed mechanism of action.&#xD;
&#xD;
      PET imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and&#xD;
      is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET&#xD;
      is now used commonly in detecting melanoma in humans as melanomas quite consistently have&#xD;
      high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has&#xD;
      not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been&#xD;
      shown to be highly predictive of outcomes of patients following radioimmunotherapy of&#xD;
      lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy&#xD;
      initiation.&#xD;
&#xD;
      In order to develop PET/CT as a tool to detect early evidence of response in patients with&#xD;
      solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT&#xD;
      imaging prior to therapy, again between days 21 and 28, and finally at 4 months&#xD;
      post-treatment initiation. Each scan will be assessed qualitatively and quantitatively.&#xD;
      Investigators will use the PERCIST criteria to determine peak and maximum standardized uptake&#xD;
      values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total glycolytic&#xD;
      volumes, and will use CT from PET/CT to measure tumor size by immune RECIST criteria. (See&#xD;
      section on Outcome Evaluation below.) Investigators will assess whether early changes in&#xD;
      tumor metabolism seen on FDG PET are predictive of progression free and overall survival&#xD;
      outcomes. Through these systematic pilot studies, investigators hope to better link FDG PET&#xD;
      measurements to individual patient responses to immune checkpoint blockade therapy and better&#xD;
      understand and refine this emerging and often effective therapeutic approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2012</start_date>
  <completion_date type="Actual">December 4, 2018</completion_date>
  <primary_completion_date type="Actual">June 2, 2014</primary_completion_date>
  <phase>Early 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>Compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria</measure>
    <time_frame>6 months after completion of standard of care treatment</time_frame>
    <description>To compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria in patients receiving immune checkpoint blockade therapy for melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC). Patients will receive 2 standard of care treatment FDG scans, the first scan at the beginning of treatment and the second scan at the end of treatment. The research scan will be done between the first and second scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the use of FDG PET as a non-invasive imaging method to detect early evidence of organ inflammation in patients receiving immune checkpoint blockade therapy</measure>
    <time_frame>6 months after completion of standard of care treatment</time_frame>
    <description>To compare FDG PET-derived SUV-based tumor metabolic activity in patients with prolonged stable partial responses to immune checkpoint blockade</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Melanoma</condition>
  <condition>Renal Cell Carcinoma (RCC)</condition>
  <condition>Non-small Cell Lung Cancer (NSCLC)</condition>
  <arm_group>
    <arm_group_label>Therapeutic response for solid tumors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients, with documented metastatic melanoma, RCC or NSCLC, about to initiate any line of immune checkpoint blockade therapy will receive a FDG PET scan during mid treatment to check for change in disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG)</intervention_name>
    <description>PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and is able to detect melanomas and other tumors, some of which are undetectable by CT.</description>
    <arm_group_label>Therapeutic response for solid tumors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years&#xD;
&#xD;
          2. Any subject with documented metastatic melanoma, RCC or NSCLC.&#xD;
&#xD;
          3. Subjects must be scheduled to receive therapy, or received only one dose, with an&#xD;
             anti-neoplastic agent that works by immune checkpoint blockade such as&#xD;
             ipilimumab/Yervoy (anti-CTLA-4), MDX-1106/BMS-936558 (anti-PD-1) or&#xD;
             MDX-1105/BMS-936559 (anti-B7-H1) mAbs.&#xD;
&#xD;
          4. Subjects must have measurable disease, defined as at least one lesion that can be&#xD;
             accurately measured in at least one dimension as &gt;10 mm with spiral CT scan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is unable to provide informed consent&#xD;
&#xD;
          2. Patient is pregnant&#xD;
&#xD;
          3. Patient enrollment on research protocol which includes an additional mid-therapy&#xD;
             investigational FDG PET/CT at approximately month from start of therapy.&#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>Evan Lipson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>May 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</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>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01666353
org study id: J1208
secondary id: NA_00049919
nct id: NCT01666353
lead sponsor: 
collaborator: 
has dmc: Yes
This study aims to develop methods for quantitative imaging of solid tumors in patients who
      are receiving immunotherapies that have a delayed mechanism of action.

      PET imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and
      is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET
      is now used commonly in detecting melanoma in humans as melanomas quite consistently have
      high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has
      not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been
      shown to be highly predictive of outcomes of patients following radioimmunotherapy of
      lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy
      initiation.

      In order to develop PET/CT as a tool to detect early evidence of response in patients with
      solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT
      imaging prior to therapy, again between days 21 and 28, and finally at 4 months
      post-treatment initiation. Each scan will be assessed qualitatively and quantitatively.
      Investigators will use the PERCIST criteria to determine peak and maximum standardized uptake
      values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total glycolytic
      volumes, and will use CT from PET/CT to measure tumor size by immune RECIST criteria. (See
      section on Outcome Evaluation below.) Investigators will assess whether early changes in
      tumor metabolism seen on FDG PET are predictive of progression free and overall survival
      outcomes. Through these systematic pilot studies, investigators hope to better link FDG PET
      measurements to individual patient responses to immune checkpoint blockade therapy and better
      understand and refine this emerging and often effective therapeutic approach.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria
time frame: 6 months after completion of standard of care treatment
description: To compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria in patients receiving immune checkpoint blockade therapy for melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC). Patients will receive 2 standard of care treatment FDG scans, the first scan at the beginning of treatment and the second scan at the end of treatment. The research scan will be done between the first and second scan.
measure: Assess the use of FDG PET as a non-invasive imaging method to detect early evidence of organ inflammation in patients receiving immune checkpoint blockade therapy
time frame: 6 months after completion of standard of care treatment
description: To compare FDG PET-derived SUV-based tumor metabolic activity in patients with prolonged stable partial responses to immune checkpoint blockade
arm group label: Therapeutic response for solid tumors
arm group type: Experimental
description: Adult patients, with documented metastatic melanoma, RCC or NSCLC, about to initiate any line of immune checkpoint blockade therapy will receive a FDG PET scan during mid treatment to check for change in disease.
intervention type: Radiation
intervention name: PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG)
description: PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and is able to detect melanomas and other tumors, some of which are undetectable by CT.
arm group label: Therapeutic response for solid tumors
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evan Lipson, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Renal Cell
mesh term: Fluorodeoxyglucose F18