Liver Biopsy
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGLumason 60.7Mg Powder for Injection
Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy
DRUGPlacebos
Placebos injected prior to ultrasound-guided biopsy
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
Patients will not be informed of diagnostic arm.
Intervention model description
Two interventional arms, selected by day of month; 1) biopsy with Lumason, 2) biopsy with placebos
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | 30 days | Biopsy sample being sufficient for histological diagnosis and/or complete genotyping. |
Countries
United States
Participant flow
Recruitment details
Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. The PI has left the institution and no information is available regarding how many participants Started and Completed the study in each arm
Participants by arm
| Arm | Count |
|---|---|
| Biopsy With Lumason Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy | 0 |
| Biopsy With Placebos Placebos injected prior to ultrasound-guided biopsy. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 30 days
Population: Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. No data were collected for Outcome Measures
Secondary
Success Rate
Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.
Time frame: 30 days
Population: Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. No data were collected for Outcome Measures