Lumason® Infusion vs. Bolus Administrations for Heart Disease

This study is looking at two different ways to give Lumason®, a medication used to improve heart imaging. Researchers want to see if giving Lumason® as a continuous infusion (slowly over time) works better than giving it as a quick bolus (a single, fast injection) for people with certain heart conditions. You might be able to join if you are at least 18 years old and have difficulty seeing parts of your heart clearly on an echocardiogram (an ultrasound of the heart). The study will compare how well each method helps visualize your heart and how well the left ventricle (the main pumping chamber of your heart) is filled with the contrast agent. The study plans to enroll 106 participants, but its current recruitment status is unclear.

Study design: This is a Phase 3 randomized study comparing two ways of giving Lumason® within the same patient. It plans to enroll 106 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The main measurements for this study will be taken 2-3 hours after the Lumason® administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Lumason® Infusion vs. Bolus Administrations

Recruiting

PHASE3Ages 18+InterventionalDiagnostic

Bracco Diagnostics, Inc

~106 participants

Updated 2026-03-05 on ClinicalTrials.gov

What's tested:Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]Lumason

At a glance

Recruiting sites

4 of 6 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Adequate LV EBD Score

Measured over 2-3 Hours

+1 more outcome measured

Conditions

Heart Diseases

Where it's being run

6 sites across 5 states

Texas2

California1

Georgia1

Massachusetts1

Oregon1

Study leadership

Jose Banchs, MD · STUDY_DIRECTOR · Sr. Medical Director

Who to contact

Rushil Sankpal

[email protected]

609-514-2267

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

Adequate LV EBD Score2-3 Hours
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.
Adequate LV Opacification2-3 Hours
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.

Trialytics