Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
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|ClinicalTrials.gov Identifier: NCT02282163|
Recruitment Status : Terminated (FDA agreed to early termination of the study due to difficulties enrolling patients.)
First Posted : November 4, 2014
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Drug: sulphur hexafluoride lipid-type A microspheres||Phase 3|
This is a Phase III, multicenter, open-label study that will be conducted at approximately 7-12 sites in the United States, Canada and Europe in pediatric patients with suboptimal LV EBD on non-contrast 2D transthoracic echocardiography with harmonic imaging. It is estimated that 92 patients will be enrolled to provide 73 evaluable patients.
Three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile will independently evaluate the echocardiograms. The efficacy analysis will be primarily based on the blinded reader evaluations.
Imaging conditions will be representative of those used in routine clinical practice and will include LV EBD with harmonic imaging modality.
One of the sites participating in this study will also be requested to consent a subset of patients for additional blood sampling for analysis of SF6 concentration in blood from a total of 6 patients (3 males and 3 females) in the age group 9 up to 12 years of age and 6 patients (3 males and 3 females) in the age of >12 up to and including 17 years.
The current study is designed to assess the efficacy of Lumason-enhanced
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Clinical Evaluation of Safety and Efficacy of Lumason as a Contrast Agent in Pediatric Echocardiography|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||August 2018|
All patients will be administered, Lumason "sulphur hexafluoride lipid-type A microspheres" an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography.
Drug: sulphur hexafluoride lipid-type A microspheres
Ultrasound imaging contrast agent
Other Name: Lumason
- To assess the eficacy of Lumason enhanced transthoracic echocardiography in pediatric subjects with suboptimal Left Ventricular Endocardial Border Delineation at unenhanced transthoracic echocardiography in terms of: [ Time Frame: Immediately post dose-Day 1 ]Change from baseline in Total Left ventricular endocardial border definition scores and Adequate Left ventricular opacification
- To obtain safety data in pediatric subjects administered Lumason for LV EBD improvement during echocardiography [ Time Frame: Up to 72 hours post dose ]Physical exam, vital signs, laboratory evaluations
- To obtain Pharmacokinetic data in a subset of subjects undergoing analysis of SF6 concentration in blood [ Time Frame: up to 15 minutes post dose ]Blood samples taken up to 15 minutes post dose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282163
|United States, Missouri|
|Washington University school of medicine in Saint Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Nebraska|
|University of Nebraska|
|Omaha, Nebraska, United States, 68114|
|Study Director:||Melda Dolan, M.D.||Bracco Diagnostics, Inc|