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Recruiting Phase 3

Lumason® Infusion vs. Bolus Administrations

NCT06400004 · tracked via the Priya Life Science USA tracker
Sponsor
Bracco Diagnostics, Inc
Phase
Phase 3
Started
2024-07-10
Last updated
2026-10-20

Condition(s) studied

Heart Diseases

Investigational drug(s) / intervention(s)

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]Lumason

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

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

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Adequate LV EBD Score — 2-3 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 Opacification — 2-3 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.

Trial sites (6)

FacilityCityRegionStatus
Interventional Cardiology Medical Group West Hills California Recruiting
Piedmont Heart Institute Atlanta Georgia Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Oregon Health and Sciences University Portland Oregon Not Yet Recruiting
University of Texas Medical Branch Galveston Texas Withdrawn
Vital Heart and Vein Humble Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06400004 on ClinicalTrials.gov ↗ ← All trials in the USA