Clinical trial NCT04324294: Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions
Official title: The Role of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pancreatitis
Pancreas Cancer
Pancreas Cyst
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The results obtained by EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis.
timeFrame: 12 months
Secondary outcomes:
measure: Quantitative Parameters of Pancreas Lesions
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Srinivas Gaddam, MD
role: PRINCIPAL_INVESTIGATOR
References: