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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Biopsy
• Intervention / Treatment: Drug: Lumason 60.7Mg Powder for Injection; Drug: Placebos

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

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Lumason
Placebo Comparator: biopsy with placebos; liver biopsy performed without prior contrast enhancement (standard method)	Drug: Placebos; Placebos injected prior to ultrasound-guided biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.	30 days

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Kumar Sandrasegaran, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1609504711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes