Contrast-Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions

What is the Purpose of this Study?

The purpose of this study is to evaluate whether contrast-enhanced endoscopic ultrasound (CE-EUS) improves the characterization of pancreas tumors and precancerous lesions, including cysts, in comparison to conventional endoscopic ultrasound (EUS). Participants will be patients who are undergoing an EUS for suspected pancreatic lesion. The study aims to learn how effective CE-EUS is in differentiating between normal and cancerous or precancerous tissue. Endoscopic ultrasound is a procedure performed with an endoscope that has an ultrasound probe at the end, where the pancreas is evaluated with the end of the endoscope located in the stomach and duodenum. In CE-EUS, the only additional step to conventional EUS is intravenous injection of contrast to evaluate lesions of interest. The goal is to determine whether the contrast agent will help to characterize pancreas lesions more favorably than conventional EUS. This study is designed to test the experimental use of Lumason and Definity. Lumason is approved by the U.S. Food and Drug Administration (FDA) for use in echocardiography and ultrasonography of the liver and urinary tract. Definity is approved by the FDA for use in routine echocardiography.


Eligibility

  • * Patients undergoing endoscopic ultrasound for pancreatic indications
  • * Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic lesions or worrisome clinical, imaging or laboratory findings
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

IIT2019-22-GADDAM-LUMASON: The Role of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions

Study Details
Disease Type/Condition

Pancreas

Principal Investigator

Gaddam, Srinivas

Co-Investigators

Ashley Wachsman, Kenneth Park, Quin Liu, Simon Lo, Stephen Pandol

Age Group

Adult

Phase

N/A (Cancer Control) (Cancer Prevention)

IRB Number

STUDY00000259

ClinicalTrials.gov ID

NCT04324294

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Pancreas

Principal Investigator

Gaddam, Srinivas

Age Group

Adult

Phase

N/A (Cancer Control) (Cancer Prevention)

IRB Number

IIT2019-22-GADDAM-LUMASON

ClinicalTrials.gov ID

NCT04324294

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org