Clinical trial · Interventional
Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions
The Role of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions
NCT04324294CI-TRIAL-00072411unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreas Cyst | — | UNRESOLVED | — |
| Pancreatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS enhanced with contrast to evaluate pancreas | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast EUS
- description
- Undergoing EUS for pancreatic indication (cyst, pancreatitis, mass)
- interventionNames
- Drug: EUS enhanced with contrast to evaluate pancreas
Primary outcomes (1)
- measure
- The results obtained by EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis.
- timeFrame
- 12 months
- description
- The endoscopist will perform conventional EUS and classify the lesion, which will be recorded by the research assistant prior to CE-EUS. Contrast will then be administered and the classification of CE-EUS will be recorded in real time. Using pathology and one-year clinical follow-up as the gold standard, the yields of the modality will be calculated. In addition, we will evaluate whether the use of CE-EUS impacted assessment of size and diagnosis.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.