Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses

As a major oncology and hepatology center, the investigators perform about 3-5 guided
biopsies for liver tumors weekly. Ultrasound is the preferred modality for imaging biopsies
due to its ability to visualize and position the biopsy needle in real time with high
accuracy and safety, is nonionizing, and is quicker compared to other techniques, especially
CT-guided biopsies. The failure rate of ultrasound guided liver biopsies (including cases
where biopsy was declined to be performed due to lack of lesion visibility) is about 10%. By
comparison, in the investigators' practice genotyping of metastatic tumors, with multiple
core biopsies, is often requested for entry into oncology trials, and failure of tumor
genotyping after biopsy is estimated to be about 30%.

Recently, the first ultrasound contrast agent was FDA-approved for characterization of liver
lesions [sulfur hexafluoride lipid-type A microspheres (Lumason, Bracco Diagnostics, Monroe
Township, NJ)]. The microbubble agent is deemed safe, including in cardiac failure patients
and those with chronic airway obstruction. Injecting microbubbles may allow better
visualization of lesions and adjacent vasculature by enhancing the microvasculature and
adjacent vessels and potentially reduce incidence of failed biopsy or bleeding
complications. In addition, determination of necrotic regions in a lesion may allow better
direction of biopsy.

Yet there is limited literature on the use of ultrasound contrast agents for improving
targeted liver biopsies. The investigators intend to prospectively assess the non-diagnostic
biopsy and complication rates in a group of patients who undergo contrast-enhanced
ultrasonography (CEUS) using microbubbles at the time of biopsy. The investigators will then
compare the results from this group with the failure and complication rate from a control
group of patients undergoing the standard US-guided biopsy procedure. Over 12 months the
investigators expect to perform approximately 200 biopsies. Power analysis suggests that 125
patients in both contrast-enhanced sonography and control groups, each, are required. The
investigators should be able to enroll sufficient patients in 18 months

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