Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions

Cedars-Sinai Medical Center

Status and phase

Enrolling

Phase 1

Conditions

Pancreatitis

Pancreas Cancer

Pancreas Cyst

Treatments

Drug: EUS enhanced with contrast to evaluate pancreas

Study type

Interventional

Funder types

Other

Identifiers

NCT04324294

STUDY00000259

Details and patient eligibility

About

The purpose of this study is to determine whether quantitative contrast-enhanced endoscopic ultrasound (CE-EUS) improves the evaluation of pancreas tumors and precursor lesions, including cysts, compared to conventional endoscopic ultrasound.

Full description

The study is a prospective trial of CE- EUS in which the conventional EUS that is part of standard clinical care is conducted after injection of intravenous contrast agent.

The study population will include those patients already undergoing endoscopic ultrasound for standard pancreatic indications at Cedars-Sinai Medical Center. The primary procedures will include conventional EUS to evaluate a pancreatic lesion as part of standard of care, IV contrast agent during the procedure if deemed necessary by the investigator, collection of time intensity curves for pancreas and lesions from the EUS processor. The study includes one standard of care visit for EUS, and the enrollment period will be 24 months. All enrolled patients will be followed by chart review or phone call for a period of 12 months.

All of the subjects will be undergoing an EUS for standard of care. These patients will also receive an IV contrast agent (Lumason) during the procedure, which is not part of standard of care, and is for research use only. FNA will be performed only on those patients deemed to require FNA based solely on the standard EUS.

If the aims of the study are achieved, it ill confirm that contrast-enhanced EUS can be used to differentiate various pancreatic lesions and, in future, may aid in risk-stratification of precursor lesions for pancreatic cancer.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Patients <18 years of age, pregnant women, and lactating mothers will be excluded.
Subjects with unstable cardiopulmonary condition will be excluded (acute myocardial infarction, acute coronary syndromes, worsening or unstable heart failure, or serious ventricular arrhythmias)
Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts will be excluded given theoretical (though clinically insignificant) risk of embolization
Patients with a history of allergy to Lumason will be excluded