<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/NCT02245217</url>
  </required_header>
  <id_info>
    <org_study_id>HCI74163</org_study_id>
    <nct_id>NCT02245217</nct_id>
  </id_info>
  <brief_title>Multi-Tracer PET Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients</brief_title>
  <official_title>Multi-Tracer Positron Emission Tomography (PET) Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2014</start_date>
  <completion_date type="Actual">March 17, 2016</completion_date>
  <primary_completion_date type="Actual">March 17, 2016</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>FDG Therapeutic Responses to 1 Cycle</measure>
    <time_frame>1 month</time_frame>
    <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as &gt;25% reduction in SUVmax.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FLT Therapeutic Responses to 1 Cycle</measure>
    <time_frame>1 month</time_frame>
    <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as &gt;25% reduction in SUVmax.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RECIST 1.1 Therapeutic Responses to 1 Cycle</measure>
    <time_frame>1 month</time_frame>
    <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a &gt;30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>PET/CT Imaging arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET/CT scan to assess treatment efficacy</intervention_name>
    <arm_group_label>PET/CT Imaging arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have either&#xD;
&#xD;
               1. histologically/cytologically-confirmed borderline resectable pancreatic cancer&#xD;
                  and be prescribed neoadjuvant gemcitabine-plus-Abraxane as part of their standard&#xD;
                  of care&#xD;
&#xD;
               2. histologically/cytologically-confirmed locally advanced unresectable pancreatic&#xD;
                  cancer and be prescribed neoadjuvant gemcitabine-plus-Abraxane as part of their&#xD;
                  standard of care.&#xD;
&#xD;
          -  Diagnostic quality abdominal imaging (CT or MRI) within the past 45 days.&#xD;
&#xD;
          -  Patients must be 18 years or older for inclusion in this research study. There is&#xD;
             little experience with the safety of fluorine-18 (18F) fluorothymidine (FLT) in&#xD;
             children and therefore this radiopharmaceutical should not be used in patients under&#xD;
             the age of 18.&#xD;
&#xD;
          -  Patients must be willing to lie flat on their back in the PET/CT scanner for up to 2&#xD;
             hours to allow the imaging data to be obtained.&#xD;
&#xD;
          -  Patients must document their willingness to be followed for up to 24 months following&#xD;
             enrollment in this imaging trial. By signing informed consent, the patients will&#xD;
             document their agreement to have clinical and radiographic endpoints and the results&#xD;
             of histopathologic tissue analysis and other laboratory information entered into a&#xD;
             research database.&#xD;
&#xD;
          -  All patients must sign a written informed consent and HIPAA authorization in&#xD;
             accordance with institutional guidelines.&#xD;
&#xD;
          -  Determination of pregnancy status: Female patients who are not postmenopausal or&#xD;
             surgically sterile will undergo a serum pregnancy test prior to baseline and the&#xD;
             subsequent set of multi-tracer PET scans. The serum pregnancy test must be performed&#xD;
             within 48 hours prior to research PET imaging. A negative test will be necessary for&#xD;
             such patients to undergo research PET imaging.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.&#xD;
&#xD;
          -  Adequate organ function and laboratory parameters as defined laboratory testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any prior systemic or investigational therapy for pancreatic cancer.&#xD;
&#xD;
          -  Patients with known allergic or hypersensitivity reactions to previously administered&#xD;
             radiopharmaceuticals (patients with significant drug or other allergies or autoimmune&#xD;
             diseases may be enrolled at the Investigator's discretion).&#xD;
&#xD;
          -  Patients who are pregnant or lactating or who suspect they might be pregnant. - Serum&#xD;
             pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET&#xD;
             scans in female patients that are not postmenopausal or surgically sterile.&#xD;
&#xD;
          -  Adult patients who require monitored anesthesia for PET scanning.&#xD;
&#xD;
          -  Patients known to be HIV positive. This is due to the potential toxicities of [18F]FLT&#xD;
             in HIV positive patients.&#xD;
&#xD;
          -  Pre-existing sensory neuropathy greater than grade 1.&#xD;
&#xD;
          -  Prior malignancy except for adequately treated basal cell skin cancer, in situ&#xD;
             cervical cancer or any other form of cancer from which the patient has been&#xD;
             disease-free for 5 years.&#xD;
&#xD;
          -  Uncontrolled diabetes or blood glucose greater than 180 mg/dl on the day of the [18F]&#xD;
             fluorodeoxyglucose (FDG) PET scan.&#xD;
&#xD;
          -  Major surgery within 4 weeks of the start of study treatment, without complete&#xD;
             recovery.&#xD;
&#xD;
          -  Any other condition that would, in the Investigator's judgment, contraindicate&#xD;
             patient's participation in the clinical study due to safety concerns or compliance&#xD;
             with clinical study procedures, e.g. infection/inflammation, intestinal obstruction,&#xD;
             social complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>February 8, 2018</results_first_submitted>
  <results_first_submitted_qc>February 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2018</results_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2021</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>Pancreatic Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PET/CT Imaging Arm</title>
          <description>Positron Emission Tomography (PET)/CT scan to assess treatment efficacy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PET/CT Imaging Arm</title>
          <description>PET/CT scan to assess treatment efficacy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" lower_limit="54" upper_limit="78"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>FDG Therapeutic Responses to 1 Cycle</title>
        <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as &gt;25% reduction in SUVmax.</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PET/CT Imaging Arm</title>
            <description>PET/CT scan to assess treatment efficacy</description>
          </group>
        </group_list>
        <measure>
          <title>FDG Therapeutic Responses to 1 Cycle</title>
          <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as &gt;25% reduction in SUVmax.</description>
          <units>participant responses based on EORTC</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FLT Therapeutic Responses to 1 Cycle</title>
        <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as &gt;25% reduction in SUVmax.</description>
        <time_frame>1 month</time_frame>
        <population>Patients who completed both baseline and follow-up imaging. A synthesis failure for FLT occurred on the follow-up imaging for one patient, so that patient was excluded from the FLT analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PET/CT Imaging Arm</title>
            <description>PET/CT scan to assess treatment efficacy</description>
          </group>
        </group_list>
        <measure>
          <title>FLT Therapeutic Responses to 1 Cycle</title>
          <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as &gt;25% reduction in SUVmax.</description>
          <population>Patients who completed both baseline and follow-up imaging. A synthesis failure for FLT occurred on the follow-up imaging for one patient, so that patient was excluded from the FLT analysis.</population>
          <units>participant responses based on EORTC</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RECIST 1.1 Therapeutic Responses to 1 Cycle</title>
        <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a &gt;30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PET/CT Imaging Arm</title>
            <description>PET/CT scan to assess treatment efficacy</description>
          </group>
        </group_list>
        <measure>
          <title>RECIST 1.1 Therapeutic Responses to 1 Cycle</title>
          <description>The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a &gt;30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion</description>
          <units>participant responses based on RECIST1.1</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>PET/CT Imaging Arm</title>
          <description>PET/CT scan to assess treatment efficacy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </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="9"/>
              </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>Josiah Hawks</name_or_title>
      <organization>Huntsman Cancer Institute</organization>
      <phone>8015850601</phone>
      <email>Josiah.Hawks@hci.utah.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/NCT02245217
org study id: HCI74163
nct id: NCT02245217
lead sponsor: 
has dmc: Yes
Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: FDG Therapeutic Responses to 1 Cycle
time frame: 1 month
description: The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.
measure: FLT Therapeutic Responses to 1 Cycle
time frame: 1 month
description: The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.
measure: RECIST 1.1 Therapeutic Responses to 1 Cycle
time frame: 1 month
description: The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a >30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion
arm group label: PET/CT Imaging arm
arm group type: Experimental
intervention type: Device
intervention name: PET/CT scan to assess treatment efficacy
arm group label: PET/CT Imaging arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 