<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/NCT01703026</url>
  </required_header>
  <id_info>
    <org_study_id>CTC0900328</org_study_id>
    <nct_id>NCT01703026</nct_id>
  </id_info>
  <brief_title>Contrast Enhanced EUS in the Evaluation of Pancreatic Cancer and Pancreatic Masses</brief_title>
  <official_title>Contrast Enhanced EUS Using Definity in the Evaluation of Pancreatic Cancer and Pancreatic Masses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changi General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to&#xD;
      detect pancreatic cancer at an earlier stage, to improve current method of T staging and&#xD;
      assessment of surgical resectability and also to distinguish between benign and malignant&#xD;
      pancreatic masses. All these will translate into better clinical outcome, and also avoid&#xD;
      unnecessary surgery in situations of unresectable cancers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">October 2011</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>
  <enrollment type="Actual">33</enrollment>
  <condition>Pancreatic Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 50 subjects will be enrolled. The study population will be drawn from patients&#xD;
        referred for EUS evaluation on basis of suspected pancreatic cancer. These patients could&#xD;
        be either from clinics or from the hospital wards.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients over a 1-year period referred for EUS examination due to&#xD;
             suspected pancreatic lesions will be enrolled.&#xD;
&#xD;
          -  Age 21 years and above.&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded.&#xD;
        These conditions are:&#xD;
&#xD;
          -  Right-to-left, bi-directional, or transient right-to-left cardiac shunts;&#xD;
&#xD;
          -  Worsening or clinically unstable congestive heart failure;&#xD;
&#xD;
          -  Acute myocardial infarction or acute coronary syndromes;&#xD;
&#xD;
          -  Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of&#xD;
             the QT interval;&#xD;
&#xD;
          -  Respiratory failure;&#xD;
&#xD;
          -  Severe emphysema, pulmonary emboli or other conditions that cause pulmonary&#xD;
             hypertension due to compromised pulmonary arterial vasculature;&#xD;
&#xD;
          -  Hypersensitivity to DEFINITY™ or its components.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Bilimoria KY, Bentrem DJ, Ko CY, Ritchey J, Stewart AK, Winchester DP, Talamonti MS. Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database. Cancer. 2007 Aug 15;110(4):738-44. doi: 10.1002/cncr.22852.</citation>
    <PMID>17580363</PMID>
  </reference>
  <reference>
    <citation>Ang TL. Endoscopic ultrasound: moving from diagnostics to therapeutics. J Dig Dis. 2008 Aug;9(3):117-28. doi: 10.1111/j.1751-2980.2008.00333.x.</citation>
    <PMID>18956589</PMID>
  </reference>
  <reference>
    <citation>Snady H, Cooperman A, Siegel J. Endoscopic ultrasonography compared with computed tomography with ERCP in patients with obstructive jaundice or small peri-pancreatic mass. Gastrointest Endosc. 1992 Jan-Feb;38(1):27-34. doi: 10.1016/s0016-5107(92)70326-5.</citation>
    <PMID>1612375</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>October 9, 2012</last_update_submitted>
  <last_update_submitted_qc>October 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2012</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>
  <!-- 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/NCT01703026
org study id: CTC0900328
nct id: NCT01703026
lead sponsor: 
has dmc: No
Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to
      detect pancreatic cancer at an earlier stage, to improve current method of T staging and
      assessment of surgical resectability and also to distinguish between benign and malignant
      pancreatic masses. All these will translate into better clinical outcome, and also avoid
      unnecessary surgery in situations of unresectable cancers.
observational model: Cohort
time perspective: Prospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Singapore
citation: Bilimoria KY, Bentrem DJ, Ko CY, Ritchey J, Stewart AK, Winchester DP, Talamonti MS. Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database. Cancer. 2007 Aug 15;110(4):738-44. doi: 10.1002/cncr.22852.
PMID: 17580363
citation: Ang TL. Endoscopic ultrasound: moving from diagnostics to therapeutics. J Dig Dis. 2008 Aug;9(3):117-28. doi: 10.1111/j.1751-2980.2008.00333.x.
PMID: 18956589
citation: Snady H, Cooperman A, Siegel J. Endoscopic ultrasonography compared with computed tomography with ERCP in patients with obstructive jaundice or small peri-pancreatic mass. Gastrointest Endosc. 1992 Jan-Feb;38(1):27-34. doi: 10.1016/s0016-5107(92)70326-5.
PMID: 1612375
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms