Clinical trial NCT02282163: Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
Official title: A Multicenter Clinical Evaluation of Safety and Efficacy of Lumason as a Contrast Agent in Pediatric Echocardiography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2014-11-04
Enrollment: 13
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 subjects represented those utilized in routine clinical practice in adults.

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-contrast 2D transthoracic echocardiography. It was estimated that 92 patients were to be enrolled to provide 73 evaluable patients.

Three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile were to independently evaluate the echocardiograms. The efficacy analysis was primarily based on the blinded reader evaluations.

Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.

One of the sites participating in this study was to be asked 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 was designed to assess the efficacy of Lumason-enhanced echocardiography in pediatric patients.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Total Left Ventricular Endocardial Border Delineation (LV EBD) Scores
timeFrame: Immediately post dose-Day 1
measure: Percentage of Participants With Adequate Left Ventricular Opacification (LVO)
timeFrame: Immediately post dose-Day 1
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 72 hours post dose
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine in Saint Louis
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Melda Dolan, M.D.
role: STUDY_DIRECTOR
References: