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3D Echocardiography for Congenital Heart Defects

Phase 1 & 2

Waitlist Available

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction) will be ineligible for the clinical ultrasound and ineligible for the study.

Pregnant women will be excluded from the study as well since Lumason has not been studied in pregnancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of initial assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial uses two echocardiographic technologies to improve accuracy of measures of right ventricular size and function, compared with MRI.

Who is the study for?

This trial is for individuals aged 11 or older with repaired congenital heart disease and residual pulmonary insufficiency who need a cardiac MRI. Participants must provide informed consent, and if under legal age, assent along with parental or guardian consent. Those allergic to Lumason or its components, with prior severe reactions to similar agents, or pregnant women cannot join.

What is being tested?

The study tests the use of three-dimensional echocardiography combined with an ultrasound enhancing agent called Lumason against cardiac MRI for measuring right ventricular size and function in patients with repaired congenital heart defects.

What are the potential side effects?

Potential side effects from Lumason may include allergic reactions such as rash, difficulty breathing, swelling of face or lips; however, these are more likely in those already sensitive to its ingredients.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had a severe allergic reaction to Lumason.

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I am not pregnant.

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I am allergic to Lumason or its components.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of initial assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of initial assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of initial assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy of 3D echocardiography based measurements of right ventricular size and function compared to MRI derived values.

Inter-rater reliability of 3D echocardiography based measurements of right ventricular size and function with and without contrast

Secondary study objectives

Echocardiography

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: diagnostic armExperimental Treatment1 Intervention

The echocardiography team will perform baseline echocardiographic views of the right ventricle without contrast. The patient will receive the weight-based dose of Lumason of 0.03 mL/kg per injection, not to exceed 2.4 mL per injection per the FDA and manufacturer recommendations. Dosages and timing of administration as well as patient size and transducer type will be recorded for each patient. The total cumulative dose of Lumason from the clinical study and the research study will not exceed the maximum recommended dose by the manufacturer, 4.8 mL. A single injection will not exceed the maximal FDA-recommended dose of 2.4 mL per single injection. These echocardiographic views of the right ventricle with ultrasound enhancing agent will be compared to the measurements made without the use of ultrasound enhancing agents, and the measurements made in MRI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2022

Completed Phase 2

~30

0 / 3Eligibility criteria met