Liver Biopsy Clinical Trial
Official title:
Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses
Verified date | July 2019 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators plan to compare complication and success rates between two methods of ultrasound guidance for biopsy of liver lesions, contrast-enhanced and the current protocol without contrast.
Status | Terminated |
Enrollment | 83 |
Est. completion date | July 6, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Males and females 2. Age 18 years or greater 3. Scheduled to undergo liver biopsy with ultrasound guidance at a performance site Exclusion Criteria: 1. Liver biopsy is not intended to obtain tissue from a specific lesion 2. Known or suspected cardiac shunt 3. History of hypersensitivity to any active or inactive ingredients in Lumason |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Health | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complication Rate | Complication will be defined as 1) bleeding seen on post-biopsy CT or US, 2) drop in hemoglobin of more than 1.5 g/dL within one week after biopsy, or 3) need for hepatic artery embolization. | 30 days | |
Secondary | Success Rate | Biopsy sample being sufficient for histological diagnosis and/or complete genotyping. | 30 days |
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