<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/NCT03820661</url>
  </required_header>
  <id_info>
    <org_study_id>18-5982</org_study_id>
    <nct_id>NCT03820661</nct_id>
  </id_info>
  <brief_title>High Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma</brief_title>
  <official_title>Advancing The Local Staging Of Pancreatic Ductal Adenocarcinoma Through High-Resolution Ultrasound: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</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>
      Pancreatic cancer patients at UHN who have had a CT at UHN and have surgery planned will&#xD;
      undergo a high resolution ultrasound pre-operatively and intra-operatively. This study is&#xD;
      being done to see if using high resolution ultrasound before and during surgery will help the&#xD;
      doctors accurately diagnose pancreatic ductal adenocarcinoma and identify if the disease has&#xD;
      spread to other areas of the body.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">November 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>High-resolution U/S will be used to measure vascular invasion and regional lymph node metastases in PDAC</measure>
    <time_frame>within 2 weeks of surgery</time_frame>
    <description>The U/S results will be compared to pre-operative CT scan to help determine the diagnostic effectiveness of High Resolution US</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>High Resolution Ultasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Diagnostic high resolution ultrasound pre-operatively and intraoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>High resolution ultrasound pre-operatively and intra-operatively</description>
    <arm_group_label>High Resolution Ultasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females &gt; 18 y&#xD;
&#xD;
          2. PDAC diagnosed by typical imaging findings or pathology&#xD;
&#xD;
          3. Scheduled for surgical resection&#xD;
&#xD;
          4. Contrast enhanced CT scan performed locally at UHN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Inability or unwillingness to provide informed consent&#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>Korosh Khalili, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UHN</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephanie Ramotar</last_name>
    <phone>416-946-4501</phone>
    <phone_ext>2657</phone_ext>
    <email>Stephanie.Ramotar@uhn.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dorian Anglin Facey</last_name>
    <phone>416 340 4800</phone>
    <phone_ext>5095</phone_ext>
    <email>dorian.facey@uhn.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dorian Facey</last_name>
      <phone>4377797757</phone>
    </contact>
    <contact_backup>
      <last_name>Stephanie Ramotar</last_name>
    </contact_backup>
    <investigator>
      <last_name>Korosh Khalili</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</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>Adenocarcinoma</mesh_term>
  </condition_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/NCT03820661
org study id: 18-5982
nct id: NCT03820661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pancreatic cancer patients at UHN who have had a CT at UHN and have surgery planned will
      undergo a high resolution ultrasound pre-operatively and intra-operatively. This study is
      being done to see if using high resolution ultrasound before and during surgery will help the
      doctors accurately diagnose pancreatic ductal adenocarcinoma and identify if the disease has
      spread to other areas of the body.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: High-resolution U/S will be used to measure vascular invasion and regional lymph node metastases in PDAC
time frame: within 2 weeks of surgery
description: The U/S results will be compared to pre-operative CT scan to help determine the diagnostic effectiveness of High Resolution US
arm group label: High Resolution Ultasound
arm group type: Other
description: Diagnostic high resolution ultrasound pre-operatively and intraoperatively
intervention type: Device
intervention name: Ultrasound
description: High resolution ultrasound pre-operatively and intra-operatively
arm group label: High Resolution Ultasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Korosh Khalili, MD
role: Principal Investigator
affiliation: UHN
last name: Stephanie Ramotar
phone: 416-946-4501
phone ext: 2657
email: Stephanie.Ramotar@uhn.ca
last name: Dorian Anglin Facey
phone: 416 340 4800
phone ext: 5095
email: dorian.facey@uhn.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Adenocarcinoma