Lumason® Infusion vs. Bolus Administrations

Bracco

Status and phase: Not yet enrolling; Phase 3

Conditions: Heart Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06400004

BR1-149

Details and patient eligibility

About

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).

Full description

This is 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). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Bolus administration

Active Comparator group

Description:

Bolus administration of 2 mL undiluted Lumason®

Treatment:

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

Continuous infusion

Experimental group

Description:

Continuous infusion of 8 mL of diluted Lumason®

Treatment:

Drug: Lumason