Continuous diluted Lumason infusion versus undiluted Lumason bolus for clearer left‑ventricle ultrasound images

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

This will test whether a continuous, diluted Lumason infusion gives clearer left‑ventricle ultrasound images than the standard undiluted Lumason bolus in adults whose left ventricle is hard to visualize.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bracco Diagnostics, Inc (industry)
• Locations: 6 sites (West Hills, California and 5 other locations)
• Trial ID: NCT06400004 on ClinicalTrials.gov

What this trial studies

This phase III, randomized within‑patient comparison has each participant receive both a continuous diluted infusion of Lumason and an undiluted bolus in randomized order to compare image quality. The co‑primary endpoints are degree of left ventricular opacification (LVO) and improvement in left ventricular endocardial border definition (LV EBD). Eligible patients are adults with suboptimal LV EBD defined as at least two adjacent segments not visualized in any apical view on pre‑contrast echocardiography. The trial is being conducted at multiple U.S. cardiac centers and uses standard echocardiographic imaging with contrast to score the endpoints.

Who should consider this trial

Good fit: Adults aged 18 or older with suboptimal LV endocardial border definition (≥2 adjacent segments not visualized in any apical view) who can give informed consent and comply with protocol requirements are ideal candidates.

Not a fit: Patients with severe NYHA class IV heart failure, uncontrolled angina, recent unstable myocardial infarction, severe arrhythmia or pulmonary hypertension, recent use of other contrast agents, or known allergy to the agent are unlikely to benefit or be eligible to participate.

Why it matters

Potential benefit: If successful, this approach could produce clearer heart ultrasound images, helping doctors make more accurate diagnoses and treatment decisions.

How similar studies have performed: Contrast echocardiography with sulfur hexafluoride microbubbles has previously improved LV opacification and border definition, but randomized within‑patient comparisons of diluted infusion versus undiluted bolus at phase III scale are limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

West Hills, California and 5 other locations

• Interventional Cardiology Medical Group — West Hills, California, United States (RECRUITING)
• Piedmont Heart Institute — Atlanta, Georgia, United States (RECRUITING)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
• Oregon Health and Sciences University — Portland, Oregon, United States (NOT_YET_RECRUITING)
• University of Texas Medical Branch — Galveston, Texas, United States (WITHDRAWN)
• Vital Heart and Vein — Humble, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Rushil Sankpal

Conditions: Heart Diseases