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

Changi General Hospital1 site in 1 country33 target enrollmentAugust 2009

ConditionsPancreatic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: Changi General Hospital
Enrollment: 33
Locations: 1
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

October 2011

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Changi General Hospital

Responsible Party

Sponsor

Eligibility 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.