A Phase 4 interventional study of Lumason 60.7Mg Powder for Injection and Placebos in Liver Biopsy, sponsored by Indiana University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-08.
Sponsored by Indiana University · Phase 4, Interventional, and Diagnostic
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.
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
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
liver biopsy performed with prior contrast enhancement with Lumason 60.7Mg Powder for Injection (experimental method)
Drug: Lumason 60.7Mg Powder for Injection
liver biopsy performed without prior contrast enhancement (standard method)
Drug: Placebos
Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy
Also known as: Lumason
Placebos injected prior to ultrasound-guided biopsy
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
Success Rate
Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.
Time frame: 30 days
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
| Milestone | Biopsy With Lumason | Biopsy With Placebos |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.
No measurements were reported for this outcome.
Collected over Insufficient patient recruitment and following internal IRB audit study was abandoned.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biopsy With Lumason | — | — | — |
| Biopsy With Placebos | — | — | — |
Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. The PI has left the institution and it is not clear if Baseline data were collected. No Baseline data are available
| Age, Categorical | Biopsy With Lumason | Biopsy With Placebos | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Biopsy With Lumason | Biopsy With Placebos | Total |
|---|
| Sex: Female, Male | Biopsy With Lumason | Biopsy With Placebos | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race and Ethnicity Not Collected | Biopsy With Lumason | Biopsy With Placebos | Total |
|---|
| Region of Enrollment(participants) | Biopsy With Lumason | Biopsy With Placebos | Total |
|---|
| Insufficient patient recruitment and data was lost following departure of key study personnel | Biopsy With Lumason | Biopsy With Placebos | Total |
|---|
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Plan to share: No
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Indiana University