NCT06400004

Lumason® Infusion vs. Bolus Administrations

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is 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). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.

Conditions

• Heart Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-10
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2024-05-06
• Last updated: 2026-03-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study