Recruiting
Phase 1

Endoscopic Ultrasound

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT04324294

Conditions

Pancreatitis

Pancreas Cancer

Pancreas Cyst

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EUS enhanced with contrast to evaluate pancreas

Study Details

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.

Conditions

Pancreatitis

Pancreas Cancer

Pancreas Cyst

Study ID

NCT04324294

Start date

Feb 26, 2020

Status verified date

Dec, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Contrast EUS

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

Interventions

EUS enhanced with contrast to evaluate pancreas

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

Primary outcome measure

  • The results obtained by EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Liliana Bancila

310 423 3872liliana.bancila@cshs.org

Srinivas Gaddam, MD

310 423 6082Srinivas.Gaddam@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Liliana Bancila

310-423-3872liliana.bancila@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Dec 20, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2023-12-20.