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Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography

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ClinicalTrials.gov Identifier: NCT02282163
Recruitment Status : Recruiting
First Posted : November 4, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

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 conditions will represent those in routine clinical practice and will include LV EBD with harmonic imaging modality.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Drug: sulphur hexafluoride lipid-type A microspheres Phase 3

Detailed Description:

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)
Estimated Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter Clinical Evaluation of Safety and Efficacy of Lumason as a Contrast Agent in Pediatric Echocardiography
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lumason
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. To otain Pharmacokinetic data in a subset of subjects undergoing analysis of SF6 concentration in blood [ Time Frame: up to 15 minutes post dose ]
    Blood sampls taken up to 15 minutes post dose



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 definition 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

Information from the National Library of Medicine

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


Contacts
Contact: Kathleen Bensel 609-514-2286 kathleen.bensel@diag.bracco.com
Contact: Anna Baratelle 609-514-2267 anna.baratelle@diag.bracco.com

Locations
United States, Missouri
Washington University school of medicine in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: GAUTAM SINGH, MD         
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States, 68114
Principal Investigator: Shelby Kutty, MD         
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Melda Dolan, M.D. Bracco Diagnostics, Inc

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT02282163     History of Changes
Other Study ID Numbers: BR1-140
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases