Using contrast-enhanced endoscopic ultrasound to evaluate pancreatic lesions
The Role of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions
This study is testing if a special type of ultrasound with contrast dye can better identify pancreatic tumors and cysts in patients than regular ultrasound.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04324294 on ClinicalTrials.gov |
What this trial studies
This study aims to assess whether quantitative contrast-enhanced endoscopic ultrasound (CE-EUS) can improve the evaluation of pancreatic tumors and precursor lesions, such as cysts, compared to conventional endoscopic ultrasound. It is a prospective trial where patients undergoing standard endoscopic ultrasound for pancreatic indications will receive an intravenous contrast agent during the procedure. The study will involve collecting time intensity curves from the EUS processor to analyze the effectiveness of CE-EUS. Participants will be followed for 12 months after the procedure to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing endoscopic ultrasound for unexplained pancreatitis, pancreatic masses, or cystic lesions.
Not a fit: Patients under 18 years old, pregnant or lactating women, and those with unstable cardiopulmonary conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the ability to differentiate between various pancreatic lesions, potentially improving patient management and outcomes.
How similar studies have performed: Other studies have shown promise with contrast-enhanced ultrasound techniques, but this specific application in pancreatic lesions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Srinivas Gaddam, MD — Cedars-Sinai Medical Center
- Study coordinator: Liliana Bancila
- Email: liliana.bancila@cshs.org
- Phone: 310 423 3872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.