Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography

• Status: Terminated
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

Criteria

Inclusion Criteria:

• Provide Written informed consent from parent(s) or legal guardian

• Provide assent when required according to local regulations

• Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease

• Undergone a previous transthoracic echocardiogram within one month prior to enrollment resulting in suboptimal left ventricular endocardial border defined as ≥ 2 contiguous segments in any given view that cannot be visualized.

Exclusion Criteria:

• Children < 9 years of age

• Previously enrolled in the study

• Administered any other contrast agent either intravascularly or orally within 48 hours of Lumason administration

• Known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of Lumason)

• Known hypersensitivity to one or more of the ingredients of the investigational product

• Received an investigational compound within 30 days before enrolling into this study

• Pregnant or lactating female

• Determined by investigator to be unsuitable for the study