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

NCT03040323 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 1609504711
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Success Rate

  30 days

Study Arms (2)

biopsy with Lumason

EXPERIMENTAL

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

Drug: Lumason 60.7Mg Powder for Injection

biopsy with placebos

PLACEBO COMPARATOR

liver biopsy performed without prior contrast enhancement (standard method)

Drug: Placebos

Interventions

Lumason 60.7Mg Powder for Injection DRUG

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

Also known as: Lumason

biopsy with Lumason

Placebos DRUG

Placebos injected prior to ultrasound-guided biopsy

biopsy with placebos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Age 18 years or greater
• Scheduled to undergo liver biopsy with ultrasound guidance at a performance site

You may not qualify if:

• Liver biopsy is not intended to obtain tissue from a specific lesion
• Known or suspected cardiac shunt
• History of hypersensitivity to any active or inactive ingredients in Lumason

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Powders; Injections

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

Insufficient patient recruitment and data was lost following departure of key study personnel

Results Point of Contact

• Title: Jordan Swensson ,MD
• Organization: Indiana University Department of Radiology

jswensso@iupui.edu

317-944-1831

Study Officials

• Kumar Sandrasegaran, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be informed of diagnostic arm.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Clinical Radiology

Model Details: Two interventional arms, selected by day of month; 1) biopsy with Lumason, 2) biopsy with placebos

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 2, 2017
• Study Start: December 22, 2016
• Primary Completion: June 30, 2018
• Study Completion: July 6, 2018
• Last Updated: August 8, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)