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Contrast Enhanced EUS in the Evaluation of Pancreatic Cancer and Pancreatic Masses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01703026
Recruitment Status : Completed
First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Pancreatic Cancer

Study Design

Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast Enhanced EUS Using Definity in the Evaluation of Pancreatic Cancer and Pancreatic Masses
Study Start Date : August 2009
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A total of 50 subjects will be enrolled. The study population will be drawn from patients referred for EUS evaluation on basis of suspected pancreatic cancer. These patients could be either from clinics or from the hospital wards.
Criteria

Inclusion Criteria:

  • Consecutive patients over a 1-year period referred for EUS examination due to suspected pancreatic lesions will be enrolled.
  • Age 21 years and above.
  • Ability to provide informed consent

Exclusion Criteria:

Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded. These conditions are:

  • Right-to-left, bi-directional, or transient right-to-left cardiac shunts;
  • Worsening or clinically unstable congestive heart failure;
  • Acute myocardial infarction or acute coronary syndromes;
  • Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval;
  • Respiratory failure;
  • Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature;
  • Hypersensitivity to DEFINITY™ or its components.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703026


Locations
Singapore
Changi General Hospital
Singapore, Singapore
Sponsors and Collaborators
Changi General Hospital