Lumason® Infusion vs. Bolus Administrations

NCT06400004 | Recruiting Phase 3 FDA Drug

• 1 other identifier: BR1-149
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 6

Brief Summary

A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (2)

• Adequate LV EBD Score

  Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.

  2-3 Hours

• Adequate LV Opacification

  Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.

  2-3 Hours

Secondary Outcomes (2)

• Clinically useful LVO

  2-3 Hours

• Adverse events

  24 Hours

Study Arms (2)

Bolus administration

ACTIVE COMPARATOR

Bolus administration of 2 mL undiluted Lumason®

Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

Continuous infusion

EXPERIMENTAL

Continuous infusion of 8 mL of diluted Lumason®

Drug: Lumason

Interventions

Lumason DRUG

Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min

Also known as: Infusion Administration

Continuous infusion

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] DRUG

Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds

Also known as: Bolus Administration

Bolus administration

Eligibility Criteria

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

You may qualify if:

• Are at least 18-years old;
• Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;
• Provide their written informed consent and are willing to comply with protocol requirements.

You may not qualify if:

• Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);
• Patient has uncontrolled angina (i.e., uncontrolled on medication);
• Patient had a recent myocardial infarction (within the last 3 days and not stabilized);
• Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;
• Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;
• Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration;
• Has any known allergy to one or more of the ingredients of the investigational product;
• Is pregnant or lactating. Exclude the possibility of pregnancy by: testing on site (serum or urine βHCG) prior to the start of investigational product administration; surgical history (e.g., tubal ligation or hysterectomy); post-menopausal with a minimum 1 year without menses;
• Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study;
• Is determined by the Investigator that the patient is clinically unsuitable for the study.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (6)

Interventional Cardiology Medical Group

West Hills, California, 91307, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

WITHDRAWN

Vital Heart and Vein

Humble, Texas, 77338, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Interventions

Suspensions

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jose Banchs, MD

  Sr. Medical Director

  STUDY DIRECTOR

Central Study Contacts

Rushil Sankpal

CONTACT

609-514-2267; rushil.sankpal@diag.bracco.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 6, 2024
• Study Start: July 10, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)