<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/NCT01703650</url>
  </required_header>
  <id_info>
    <org_study_id>SNUH_ISS_2012</org_study_id>
    <nct_id>NCT01703650</nct_id>
  </id_info>
  <brief_title>Role of Perfusion CT in Pancreatic Cancer</brief_title>
  <official_title>Evaluation of Diagnostic Efficacy of Perfusion CT Using Wide Detector for Staging and Response Prediction After Chemotherapy in Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is&#xD;
&#xD;
        1. to determine whether the perfusion parameters in the normal pancreas and the pancreas&#xD;
           cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT&#xD;
&#xD;
        2. to determine whether initial perfusion parameters as well as perfusion parameter change&#xD;
           in pancreas adenocarcinoma before and after chemotherapy are different between&#xD;
           chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD,&#xD;
           PD according to RECIST 1.1).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Performance of preoperative perfusion CT for preoperative staging is assessed by&#xD;
           comparing with operative finding and histologic disease staging&#xD;
&#xD;
        2. Estimation of initial or change of pancreas cancer perfusion parameters and whether&#xD;
           those can provide cut-off value for predicting response of chemotherapy in patients with&#xD;
           pancreas adenocarcinoma&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy</measure>
    <time_frame>after 6 cycles of the planned chemotherapy</time_frame>
    <description>Initial perfusion parameters (blood volume, blood flow and permeability) are compared between CTx-responder and non-responders after 6 cycle of the scheduled chemotherapy, using RECIST 1.1 criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between change of perfusion parameters and the chemotherapy response</measure>
    <time_frame>after 6 cycles of the chemotherapy</time_frame>
    <description>Perfusion parameters (blood volume, blood flow, and permeability) change between initial perfusion CT and second perfusion CT (which is taken after 2 cycle of the CTx) are compared between CTx-responder and non-responder after finishing 6 cycles of CTx according to RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perfusion parameters among different pancreas tumors</measure>
    <time_frame>within 2 months after finishing enrollment</time_frame>
    <description>Perfusion parameters (blood volume, blood flow and permeability) are compared among the different types of the pancreas tumors to investigate perfusion parameters can help characterization of the tumors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of perfusion parameters among the pancreas tumors and parenchyma</measure>
    <time_frame>within three weeks before pancreas tumor surgery</time_frame>
    <description>blood volume, blood flow and permeability are compared between the tumor and the pancreas parenchyma.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">48</enrollment>
  <condition>Adenocarcinoma, Pancreas</condition>
  <condition>Neuroendocrine Carcinoma of Pancreas</condition>
  <arm_group>
    <arm_group_label>Resectable pancreas cancer</arm_group_label>
    <description>patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Locally advanced Pancreas cancer</arm_group_label>
    <description>Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>iopromide</intervention_name>
    <description>iopromide (370mgI/mL) enhanced perfusion CT will be performed within 14 days of operation.&#xD;
In patients who are planned to receive chemotherapy, iopromide enhanced perfusion CT was performed twice; within 14 days before starting 1st cycle and within 14 days after finishing 2nd cycle.&#xD;
iopromide (370mgI/mL) will be administered intravenously with an amount of 30mL (body weight[BW] &lt;50kg) or 35 mL (50kg ≤BW &lt;70kg) or 40 mL (70 kg≤BW &lt;90kg) or 50 mL (90≤BW), followed by saline infusion (30mL).&#xD;
Injection rate is as follows; 6.0mL/sec if BW is &lt;50kg, 7.0 mL/sec if BW is 50kg≤and &lt;70kg, 8.0 mL/sec if BW is 70≤and&lt;90kg and 9.0mL/sec if BW is 90kg≤.</description>
    <arm_group_label>Locally advanced Pancreas cancer</arm_group_label>
    <arm_group_label>Resectable pancreas cancer</arm_group_label>
    <other_name>Ultravist® (370mgI/mL)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CT</intervention_name>
    <description>Perfusion CT will be performed by using a 320 channel MDCT&#xD;
Patients are requested for fasting for at least 8 hours before CT scan.&#xD;
Patients are requested for doing shallow breathing as slow as possible and wide strap is applied during CT scan.&#xD;
Scan range is limited to the whole pancreas and it focuses to the pancreas tumor lesion.&#xD;
During perfusion CT, 19 phases (ten phases with two seconds interval and six phases with three seconds interval and three phases with five seconds interval) are obtained in fifty three seconds.&#xD;
ADIR 3D and SURE EXPOSURE 3D are applied during perfusion CT to minimize radiation dose.</description>
    <arm_group_label>Locally advanced Pancreas cancer</arm_group_label>
    <arm_group_label>Resectable pancreas cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Resectable pancreas tumor group patients with resectable pancreas adenocarcinoma or&#xD;
        neuroendocrine tumor&#xD;
&#xD;
        Locally advanced pancreas tumor group Patients with locally advanced pancreas cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are older than eighteen years&#xD;
&#xD;
          -  patients in whom operation and preoperative computed tomography are scheduled for&#xD;
             resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor&#xD;
&#xD;
          -  patients in whom chemotherapy is scheduled for histologically confirmed pancreas&#xD;
             adenocarcinoma&#xD;
&#xD;
          -  patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma&#xD;
             on imaging workup&#xD;
&#xD;
          -  patients who agree with the study and whose informed consent is obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who are younger than eighteen years old&#xD;
&#xD;
          -  patients in whom previously radiation therapy was performed and the RTx field includes&#xD;
             pancreas&#xD;
&#xD;
          -  patients with recurred pancreas adenocarcinoma&#xD;
&#xD;
          -  patient who are pregnant or nursing patients&#xD;
&#xD;
          -  patients with renal failure (GFR&lt;30mL/min)&#xD;
&#xD;
          -  patients with history of malignancy, except malignancy is in complete remission after&#xD;
             operation or iodine therapy for at least five years)&#xD;
&#xD;
          -  patients with hypersensitivity for iodine or contrast media or other causes of&#xD;
             contraindication of contrast-media enhanced CT scan&#xD;
&#xD;
          -  Any other condition which, in the opinion of the Investigator, would make the patient&#xD;
             unsuitable for enrollment or could interfere with the completion of the study.&#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>Jeong Min Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>October 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong Min Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>CT</keyword>
  <keyword>pancreas adenocarcinoma</keyword>
  <keyword>RECIST</keyword>
  <keyword>perfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
  </condition_browse>
  <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/NCT01703650
org study id: SNUH_ISS_2012
nct id: NCT01703650
lead sponsor: 
has dmc: Yes
The purpose of this study is

        1. to determine whether the perfusion parameters in the normal pancreas and the pancreas
           cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT

        2. to determine whether initial perfusion parameters as well as perfusion parameter change
           in pancreas adenocarcinoma before and after chemotherapy are different between
           chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD,
           PD according to RECIST 1.1).
1. Performance of preoperative perfusion CT for preoperative staging is assessed by
           comparing with operative finding and histologic disease staging

        2. Estimation of initial or change of pancreas cancer perfusion parameters and whether
           those can provide cut-off value for predicting response of chemotherapy in patients with
           pancreas adenocarcinoma
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy
time frame: after 6 cycles of the planned chemotherapy
description: Initial perfusion parameters (blood volume, blood flow and permeability) are compared between CTx-responder and non-responders after 6 cycle of the scheduled chemotherapy, using RECIST 1.1 criteria.
measure: Correlation between change of perfusion parameters and the chemotherapy response
time frame: after 6 cycles of the chemotherapy
description: Perfusion parameters (blood volume, blood flow, and permeability) change between initial perfusion CT and second perfusion CT (which is taken after 2 cycle of the CTx) are compared between CTx-responder and non-responder after finishing 6 cycles of CTx according to RECIST 1.1 criteria.
measure: Perfusion parameters among different pancreas tumors
time frame: within 2 months after finishing enrollment
description: Perfusion parameters (blood volume, blood flow and permeability) are compared among the different types of the pancreas tumors to investigate perfusion parameters can help characterization of the tumors.
measure: comparison of perfusion parameters among the pancreas tumors and parenchyma
time frame: within three weeks before pancreas tumor surgery
description: blood volume, blood flow and permeability are compared between the tumor and the pancreas parenchyma.
arm group label: Resectable pancreas cancer
description: patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration
arm group label: Locally advanced Pancreas cancer
description: Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy.
intervention type: Drug
intervention name: iopromide
description: iopromide (370mgI/mL) enhanced perfusion CT will be performed within 14 days of operation.
In patients who are planned to receive chemotherapy, iopromide enhanced perfusion CT was performed twice; within 14 days before starting 1st cycle and within 14 days after finishing 2nd cycle.
iopromide (370mgI/mL) will be administered intravenously with an amount of 30mL (body weight[BW] <50kg) or 35 mL (50kg ≤BW <70kg) or 40 mL (70 kg≤BW <90kg) or 50 mL (90≤BW), followed by saline infusion (30mL).
Injection rate is as follows; 6.0mL/sec if BW is <50kg, 7.0 mL/sec if BW is 50kg≤and <70kg, 8.0 mL/sec if BW is 70≤and<90kg and 9.0mL/sec if BW is 90kg≤.
arm group label: Locally advanced Pancreas cancer
arm group label: Resectable pancreas cancer
other name: Ultravist® (370mgI/mL)
intervention type: Procedure
intervention name: CT
description: Perfusion CT will be performed by using a 320 channel MDCT
Patients are requested for fasting for at least 8 hours before CT scan.
Patients are requested for doing shallow breathing as slow as possible and wide strap is applied during CT scan.
Scan range is limited to the whole pancreas and it focuses to the pancreas tumor lesion.
During perfusion CT, 19 phases (ten phases with two seconds interval and six phases with three seconds interval and three phases with five seconds interval) are obtained in fifty three seconds.
ADIR 3D and SURE EXPOSURE 3D are applied during perfusion CT to minimize radiation dose.
arm group label: Locally advanced Pancreas cancer
arm group label: Resectable pancreas cancer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeong Min Lee, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong Min Lee
investigator title: Professor
mesh term: Adenocarcinoma
mesh term: Pancreatic Neoplasms
mesh term: Carcinoma, Neuroendocrine
sharing ipd: No