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Lumason® Infusion vs. Bolus Administrations

NCT06400004 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-03-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Bracco Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • Jose Banchs, MD · Sr. Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2026-05-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400004 on ClinicalTrials.gov