<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/NCT03012282</url>
  </required_header>
  <id_info>
    <org_study_id>9625</org_study_id>
    <secondary_id>NCI-2016-01780</secondary_id>
    <secondary_id>9625</secondary_id>
    <secondary_id>RG3017007</secondary_id>
    <nct_id>NCT03012282</nct_id>
  </id_info>
  <brief_title>CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic Cancer</brief_title>
  <official_title>Evaluation of CT Perfusion Parameters as a Potential Biomarker for Treatment Response in Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well computed tomography (CT) perfusion images work in&#xD;
      assessing treatment response in patients with pancreatic cancer. Analyzing specific&#xD;
      measurements on the CT perfusion images may help doctors better determine how a tumor&#xD;
      responds to chemotherapy and/or radiation therapy and may help guide treatment for patients&#xD;
      with pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE:&#xD;
&#xD;
      Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard&#xD;
      of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy,&#xD;
      at 4-6 weeks after radiation therapy, or prior to definitive surgery.&#xD;
&#xD;
      After completion of the study, patients are followed up periodically for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Termination due to slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">June 22, 2017</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Assessed using logistic regression. Receiver operating characteristic (ROC) curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between pre-treatment CT tumor perfusion parameters and tumor response after treatment</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Assessed using logistic regression. ROC curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter. If multiple perfusion parameters are found to be predictive of response, a multivariate logistic regression model will be constructed with these variables. ROC analysis will also be used to summary the predictive performance of the multivariate model.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of pre-treatment CT tumor perfusion parameters with overall survival</measure>
    <time_frame>At 1 year</time_frame>
    <description>Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of pre-treatment CT tumor perfusion parameters with overall survival</measure>
    <time_frame>At 2 years</time_frame>
    <description>Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of pre-treatment CT tumor perfusion parameters with progression free survival</measure>
    <time_frame>At 1 year</time_frame>
    <description>Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of pre-treatment CT tumor perfusion parameters with progression free survival</measure>
    <time_frame>At 2 years</time_frame>
    <description>Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in computed tomography (CT) tumor perfusion parameters (time to peak concentration)</measure>
    <time_frame>Baseline to post-treatment (up to approximately one year)</time_frame>
    <description>The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CT tumor perfusion parameter (blood flow)</measure>
    <time_frame>Baseline to post-treatment (up to approximately one year)</time_frame>
    <description>The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CT tumor perfusion parameter (blood volume)</measure>
    <time_frame>Baseline to post-treatment (up to approximately one year)</time_frame>
    <description>The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CT tumor perfusion parameter (Ktrans)</measure>
    <time_frame>Baseline to post-treatment (up to approximately one year)</time_frame>
    <description>The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Diagnostic (CT perfusion sequence)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Computed Tomography Perfusion Imaging</intervention_name>
    <description>Undergo CT perfusion sequence</description>
    <arm_group_label>Diagnostic (CT perfusion sequence)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
          -  A diagnosis of pancreatic ductal adenocarcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to provide informed consent&#xD;
&#xD;
          -  Women who are pregnant or intending to become pregnant during the study&#xD;
&#xD;
          -  Patients with body mass index greater than 40 kg/m^2&#xD;
&#xD;
          -  History of severe allergic-like reaction to iodinated contrast media&#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>Ryan O'Malley</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>June 30, 2022</last_update_submitted>
  <last_update_submitted_qc>June 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03012282
org study id: 9625
secondary id: NCI-2016-01780
secondary id: 9625
secondary id: RG3017007
nct id: NCT03012282
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot clinical trial studies how well computed tomography (CT) perfusion images work in
      assessing treatment response in patients with pancreatic cancer. Analyzing specific
      measurements on the CT perfusion images may help doctors better determine how a tumor
      responds to chemotherapy and/or radiation therapy and may help guide treatment for patients
      with pancreatic cancer.
OUTLINE:

      Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard
      of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy,
      at 4-6 weeks after radiation therapy, or prior to definitive surgery.

      After completion of the study, patients are followed up periodically for 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy
time frame: Up to 4 years
description: Assessed using logistic regression. Receiver operating characteristic (ROC) curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter.
measure: Correlation between pre-treatment CT tumor perfusion parameters and tumor response after treatment
time frame: Up to 1 year
description: Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Assessed using logistic regression. ROC curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter. If multiple perfusion parameters are found to be predictive of response, a multivariate logistic regression model will be constructed with these variables. ROC analysis will also be used to summary the predictive performance of the multivariate model.
measure: Correlation of pre-treatment CT tumor perfusion parameters with overall survival
time frame: At 1 year
description: Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
measure: Correlation of pre-treatment CT tumor perfusion parameters with overall survival
time frame: At 2 years
description: Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
measure: Correlation of pre-treatment CT tumor perfusion parameters with progression free survival
time frame: At 1 year
description: Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
measure: Correlation of pre-treatment CT tumor perfusion parameters with progression free survival
time frame: At 2 years
description: Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
measure: Change in computed tomography (CT) tumor perfusion parameters (time to peak concentration)
time frame: Baseline to post-treatment (up to approximately one year)
description: The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
measure: Change in CT tumor perfusion parameter (blood flow)
time frame: Baseline to post-treatment (up to approximately one year)
description: The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
measure: Change in CT tumor perfusion parameter (blood volume)
time frame: Baseline to post-treatment (up to approximately one year)
description: The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
measure: Change in CT tumor perfusion parameter (Ktrans)
time frame: Baseline to post-treatment (up to approximately one year)
description: The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
arm group label: Diagnostic (CT perfusion sequence)
arm group type: Experimental
description: Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery.
intervention type: Diagnostic Test
intervention name: Computed Tomography Perfusion Imaging
description: Undergo CT perfusion sequence
arm group label: Diagnostic (CT perfusion sequence)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ryan O'Malley
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No