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RECRUITING
NCT06400004
PHASE3

Lumason® Infusion vs. Bolus Administrations

Sponsor: Bracco Diagnostics, Inc

View on ClinicalTrials.gov

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).

Official title: A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2024-07-10

Completion Date

2026-12-31

Last Updated

2026-03-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

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

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

DRUG

Lumason

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

Locations (6)

Interventional Cardiology Medical Group

West Hills, California, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Oregon Health and Sciences University

Portland, Oregon, United States

University of Texas Medical Branch

Galveston, Texas, United States

Vital Heart and Vein

Humble, Texas, United States