Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
Stopped early · Phase 3
Conditions studied: Heart Disease
In brief
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.
Key facts
- Study ID
- NCT02282163
- Run by
- Bracco Diagnostics, Inc
- People needed
- 13
- Starts
- 2015-10-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2020-07-13
Who can join
Age: 9 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine in Saint Louis — St Louis, Missouri, United States
- University of Nebraska — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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