Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions

NCT ID: NCT04324294

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2025-12-31

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.

Conditions

Pancreatitis; Pancreas Cancer; Pancreas Cyst

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Contrast EUS

Undergoing EUS for pancreatic indication (cyst, pancreatitis, mass)

Group Type: EXPERIMENTAL

EUS enhanced with contrast to evaluate pancreas

Intervention Type: DRUG

Patients will receive intravenous contrast during EUS to assess whether it improves the evaluation of pancreas.

Interventions

EUS enhanced with contrast to evaluate pancreas

Patients will receive intravenous contrast during EUS to assess whether it improves the evaluation of pancreas.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Srinivas Gaddam

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Srinivas Gaddam, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Liliana Bancila

Role: CONTACT

liliana.bancila@cshs.org

310 423 3872

Srinivas Gaddam, MD

Role: CONTACT

Srinivas.Gaddam@cshs.org

310 423 6082

Facility Contacts

Liliana Bancila

Role: primary

liliana.bancila@cshs.org

310-423-3872

Other Identifiers

STUDY00000259

Identifier Type: -

Identifier Source: org_study_id