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Ultrasound Contrast Agent

Lumason Administration Methods for Heart Disease

Phase 3
Waitlist Available
Research Sponsored by Bracco Diagnostics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patient has uncontrolled angina (i.e., uncontrolled on medication)
Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two ways of giving Lumason® to see which one is better for assessing certain heart conditions.

Who is the study for?
This trial is for individuals with heart disease who can safely receive Lumason, a diagnostic drug used in ultrasounds. Participants must be eligible based on specific health criteria not detailed here.
What is being tested?
The study compares two ways of giving Lumason: a continuous diluted infusion versus a single concentrated dose (bolus). It measures how well each method shows left ventricular opacification and endocardial border definition during an ultrasound.
What are the potential side effects?
Lumason may cause side effects like headache, nausea, or uncommon allergic reactions. The way it's given might affect the likelihood or severity of these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My heart's left ventricle has areas that can't be seen clearly on an echo without contrast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My chest pain is not controlled by medication.
Select...
I have severe heart failure (NYHA class IV).
Select...
I recently had a heart attack and am not yet stable.
Select...
I have not had any contrast agents for scans within the last 48 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adequate LV EBD Score
Adequate LV Opacification
Secondary study objectives
Adverse events
Clinically useful LVO

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous infusionExperimental Treatment1 Intervention
Continuous infusion of 8 mL of diluted Lumason®
Group II: Bolus administrationActive Control1 Intervention
Bolus administration of 2 mL undiluted Lumason®
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumason
2015
Completed Phase 4
~400

Find a Location

Who is running the clinical trial?

Bracco Diagnostics, IncLead Sponsor
61 Previous Clinical Trials
10,965 Total Patients Enrolled
Jose Banchs, MDStudy DirectorSr. Medical Director
1 Previous Clinical Trials
45 Total Patients Enrolled
~71 spots leftby Nov 2025
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