Lumason Administration Methods for Heart Disease

Recruiting at 2 trial locations

Overseen By Audrey Sahns

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bracco Diagnostics, Inc

Disqualifiers: Severe heart failure, Uncontrolled angina, Recent myocardial infarction, Severe arrhythmia, Severe pulmonary hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2-3 hours

106 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Jose Banchs, MD

Principal Investigator

Sr. Medical Director

Eligibility Criteria

This trial is for individuals with heart disease who can safely receive Lumason, a diagnostic drug used in ultrasounds. Participants must be eligible based on specific health criteria not detailed here.

Inclusion Criteria

Provide their written informed consent and are willing to comply with protocol requirements

My heart's left ventricle has areas that can't be seen clearly on an echo without contrast.

Exclusion Criteria

Has any known allergy to one or more of the ingredients of the investigational product

Is determined by the Investigator that the patient is clinically unsuitable for the study

Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Randomized, within-patient comparison of continuous infusion of diluted Lumason® versus bolus administration of undiluted Lumason®

2-3 hours

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and effectiveness after treatment

24 hours

Treatment Details

Interventions

• Lumason®

Trial Overview The study compares two ways of giving Lumason: a continuous diluted infusion versus a single concentrated dose (bolus). It measures how well each method shows left ventricular opacification and endocardial border definition during an ultrasound.

Participant Groups

Group I: Continuous infusion Experimental Treatment 1 Intervention

Continuous infusion of 8 mL of diluted Lumason®

Group II: Bolus administration Active Control 1 Intervention

Bolus administration of 2 mL undiluted Lumason®

Who Is Running the Clinical Trial?

Bracco Diagnostics, Inc

Lead Sponsor

Trials

62

Recruited

9,500+

Diana Bracco

Bracco Diagnostics, Inc

Chief Executive Officer since 1999

Degree in Chemistry from the University of Pavia

Alberto Spinazzi

Bracco Diagnostics, Inc

Chief Medical Officer since 2023

MD