Status:
TERMINATED
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Heart Disease
Eligibility:
All Genders
9-17 years
Phase:
PHASE3
Brief 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...
Detailed Description
This was a Phase III, multicenter, open-label study that was to be conducted at approximately 7-12 sites in the United States, Canada and Europe in pediatric patients with suboptimal LV EBD on non-con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02282163
Start Date
October 1 2015
End Date
August 1 2018
Last Update
July 13 2020
Active Locations (2)
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1
Washington University School of Medicine in Saint Louis
St Louis, Missouri, United States, 63110
2
University of Nebraska
Omaha, Nebraska, United States, 68114