Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses
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|ClinicalTrials.gov Identifier: NCT03040323|
Recruitment Status : Terminated (Insufficient patient recruitment. Data lost following departure of key personnel)
First Posted : February 2, 2017
Results First Posted : July 24, 2019
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Biopsy||Drug: Lumason 60.7Mg Powder for Injection Drug: Placebos||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two interventional arms, selected by day of month; 1) biopsy with Lumason, 2) biopsy with placebos|
|Masking Description:||Patients will not be informed of diagnostic arm.|
|Official Title:||Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses|
|Actual Study Start Date :||December 22, 2016|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||July 6, 2018|
Experimental: biopsy with Lumason
liver biopsy performed with prior contrast enhancement with Lumason 60.7Mg Powder for Injection (experimental method)
Drug: Lumason 60.7Mg Powder for Injection
Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy
Other Name: Lumason
Placebo Comparator: biopsy with placebos
liver biopsy performed without prior contrast enhancement (standard method)
Placebos injected prior to ultrasound-guided biopsy
- Complication Rate [ Time Frame: 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.
- Success Rate [ Time Frame: 30 days ]Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040323
|United States, Indiana|
|Indiana University Health|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Kumar Sandrasegaran, MD||Indiana University|