Lumason® Infusion vs. Bolus Administrations

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06400004
• Other study ID #: BR1-149
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 30, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Bracco Diagnostics, Inc
• Contact: Rushil Sankpal
• Phone: 609-514-2267
• Email: rushil.sankpal[@]diag.bracco.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ßHCG) 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.

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate LV EBD Score	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.	2-3 Hours
Primary	Adequate LV Opacification	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.	2-3 Hours
Secondary	Clinically useful LVO	To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration	2-3 Hours
Secondary	Adverse events	Compare adverse event rate after infusion vs. bolus administrations	24 Hours