Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography

NCT02282163 | Terminated Phase 3 Results DMC

• 1 other identifier: BR1-140
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.

Conditions

Heart Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Total Left Ventricular Endocardial Border Delineation (LV EBD) Scores

  The total LV EBD score for a subject was the total of the EBD scores (Inadequate - 0, sufficient - 1, Good - 2) from the 17 segments (from the apical 4-chamber, apical 2-chamber and apical long (3-chamber) views, according to the guidelines of the American Society of Echocardiography). The total LV EBD scores could range from 0 to 34 and are presented below for each of the three readers for both unenhanced ultrasound (UEUS) and contrast-enhanced ultrasound (CEUS). Change from baseline is the difference between UEUS and CEUS in total LV EBD scores.

  Immediately post dose-Day 1

• Percentage of Participants With Adequate Left Ventricular Opacification (LVO)

  LVO was graded as 0 to +3, 4-point rating scale. Left ventricular opacification rating of +2 (non-homogeneous) or +3 (complete and homogeneous) was considered as adequate LVO.

  Immediately post dose-Day 1

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Up to 72 hours post dose

Study Arms (1)

Lumason

EXPERIMENTAL

All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography.

Drug: sulphur hexafluoride lipid-type A microspheres

Interventions

sulphur hexafluoride lipid-type A microspheres DRUG

Ultrasound imaging contrast agent

Also known as: Lumason, SonoVue

Lumason

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Provide Written informed consent from parent(s) or legal guardian
• Provide assent when required according to local regulations
• Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
• Undergone a previous transthoracic echocardiogram within one month prior to enrollment resulting in suboptimal left ventricular endocardial border defined as ≥ 2 contiguous segments in any given view that cannot be visualized.

You may not qualify if:

• Children \< 9 years of age
• Previously enrolled in the study
• Administered any other contrast agent either intravascularly or orally within 48 hours of Lumason administration
• Known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of Lumason)
• Known hypersensitivity to one or more of the ingredients of the investigational product
• Received an investigational compound within 30 days before enrolling into this study
• Pregnant or lactating female
• Determined by investigator to be unsuitable for the study

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (2)

Washington University School of Medicine in Saint Louis

St Louis, Missouri, 63110, United States

Location

University of Nebraska

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

• Title: Melda S. Dolan, MD, FACC, FASE, Head, Medical Affairs and Cardiac Ultrasound Programs
• Organization: Bracco Diagnostics Inc.

Melda.Dolan@diag.bracco.com

1-609-514-2506

Study Officials

• Melda Dolan, M.D.

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 4, 2014
• Study Start: October 1, 2015
• Primary Completion: May 31, 2018
• Study Completion: August 1, 2018
• Last Updated: July 13, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)