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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
Sponsor:
Information provided by (Responsible Party):
Jordan K. Swensson, Indiana University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Biopsy Drug: Lumason 60.7Mg Powder for Injection Drug: Placebos Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two interventional arms, selected by day of month; 1) biopsy with Lumason, 2) biopsy with placebos
Masking: Single (Participant)
Masking Description: Patients will not be informed of diagnostic arm.
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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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 Name: Lumason
Placebo Comparator: biopsy with placebos
liver biopsy performed without prior contrast enhancement (standard method)
 Drug: Placebos
Placebos injected prior to ultrasound-guided biopsy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Success Rate [ Time Frame: 30 days ]
    Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Kumar Sandrasegaran, MD Indiana University
  Study Documents (Full-Text)

Documents provided by Jordan K. Swensson, Indiana University:
Study Protocol  [PDF] August 24, 2016
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: Jordan K. Swensson, Assistant Professor Clinical Radiology, Indiana University
ClinicalTrials.gov Identifier: NCT03040323    
Other Study ID Numbers: 1609504711
First Posted: February 2, 2017    Key Record Dates
Results First Posted: July 24, 2019
Last Update Posted: August 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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