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

NCT ID: NCT03040323

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-22
• Study Completion Date: 2018-07-06

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

Conditions

Liver Biopsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

biopsy with Lumason

liver biopsy performed with prior contrast enhancement with Lumason 60.7Mg Powder for Injection (experimental method)

Group Type: EXPERIMENTAL

Lumason 60.7Mg Powder for Injection

Intervention Type: DRUG

Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy

biopsy with placebos

liver biopsy performed without prior contrast enhancement (standard method)

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebos injected prior to ultrasound-guided biopsy

Interventions

Lumason 60.7Mg Powder for Injection

Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy

Intervention Type: DRUG

Placebos

Placebos injected prior to ultrasound-guided biopsy

Intervention Type: DRUG

Other Intervention Names

Lumason

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jordan K. Swensson

Assistant Professor Clinical Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kumar Sandrasegaran, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Health

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1609504711

Identifier Type: -

Identifier Source: org_study_id