Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Evaluation of the Efficacy of Contrast Enhanced Ultrasound Compared to MRI for Differentiation of Hepatic Lesions

ID
Name
RADY-SWENSSON
Description
In patients with hepatic lesions, to evaluate the efficacy of contrast enhanced ultrasound compared to MRI in differentiating focal nodular hyperplasia and hepatic adenoma.
Trial arms
Trial start
2019-02-25
Estimated PCD
2023-08-09
Trial end
2023-08-09
Status
Completed
Phase
Early phase I
Treatment
Sulfur Hexafluoride Microspheres
2.5 mL intravenous injection given at the time of ultrasound, with second 2.5 mL intravenous injection given during ultrasound as needed to improve visualization
Arms:
One: Patient population with hepatic lesion(s)
Other names:
Lumason
Size
47
Primary endpoint
new method diagnosing hepatic lesions
Two years
Eligibility criteria
Inclusion Criteria: 1. Males and females 2. Age 18 years or greater 3. Scheduled to undergo abdominal MRI with contrast at a performance site for evaluation of a hepatic lesion(s). Exclusion criteria: 1. History of cardiac shunting 2. History of acute cardiac ischemia 3. History of hypersensitivity reaction to Lumason
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 47, 'type': 'ACTUAL'}}
Updated at
2023-08-21

1 organization

1 product

1 indication

Organization
Indiana University
Product
Sulfur Hexafluoride
Indication
Liver Disease