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Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions
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 Start (Actual) 26 February 2020
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 March 2020
  • First Submitted that Met QC Criteria 25 March 2020
  • First Posted 27 March 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 December 2023
  • Last Update Posted 20 December 2023
  • Last Verified December 2023
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