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Study to Determine Dosage of OPTISON in Pediatric Patients

Primary Purpose

Study to Determine Dosage of OPTISON in Children Between ≥9 and <18 Years of Age Weighing ≥20 kg

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Optison
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Study to Determine Dosage of OPTISON in Children Between ≥9 and <18 Years of Age Weighing ≥20 kg focused on measuring Contrast-enhanced echocardiography (CE-ECHO), Transthoracic echocardiogram, Child, Left ventricular opacification (LVO), Left ventricular ejection fraction (LVEF), Left ventricular endocardial border delineation (LV EBD)

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject is between ≥9 and <18 years of age and weighs ≥20 kg.
  • The subject is clinically indicated to undergo a transthoracic echocardiogram.
  • The subject has a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized.
  • The subject is able to comply with study procedures.
  • A parent or legal guardian of the subject has signed and dated an informed consent form.

Exclusion Criteria:

  • The subject was previously enrolled in this study.
  • The subject has received an investigational medicinal product within 30 days before or is scheduled to receive one from time of entry into this study until completion of the follow-up period proposed for this study.
  • The subject has a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin.
  • The subject has pulmonary hypertension or unstable cardiopulmonary conditions.
  • The subject has severe liver disease based on medical history.
  • The subject had a recent (<6 months) neurological event.
  • The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.

Sites / Locations

  • Phoenix Children's Hospital
  • Children's Hospital Los Angeles
  • MCG Health, Inc.
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Johns Hopkins University School of Medicine
  • Cohen Children's Medical Center of New York
  • Cleveland Clinic Foundation
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients with body weight ≥20 to ≤28 kg

Patients with body weight >28 to ≤40 kg

Patients with body weight >40 kg

Arm Description

In children weighing ≥20 to ≤28 kg, 0.1 or 0.2 mL of OPTISON per injection will be given in ascending order. The cumulative dose will not exceed 1.0 mL.

If children weigh >28-≤40 kg, 0.2 or 0.3 mL of OPTISON per injection will be administered in ascending order with total dose not to exceed 1.5 mL.

For children whose weight is >40 kg, 0.2 or 0.4 mL of OPTISON per injection will be administered in ascending order with total dose not to exceed 1.8 mL.

Outcomes

Primary Outcome Measures

Visualization of the 12 segments of the left ventricle wall in standard apical 4-chamber and 2-chamber views measured by the qualitative endocardial border delineation (EBD) visualization scale.
A qualitative score will be assigned to each left ventricle (LV) segment: 0 = no visualization of the LV endocardial border = poor visualization = fair visualization = good/optimal visualization

Secondary Outcome Measures

Overall safety profile in terms of occurrence of adverse events (AEs) following administration of OPTISON.
Overall safety profile in terms of changes in measurements of systolic and diastolic blood pressure following administration of OPTISON.
Overall safety profile in terms of changes in heart rate following administration of OPTISON.
Overall safety profile in terms of changes in respiratory rate following administration of OPTISON.
Overall safety profile in terms of changes in pulse oximetry following administration of OPTISON.
Overall safety profile in terms of arterial oxygen saturation (SaO2) following administration of OPTISON.
Overall safety profile in terms of physical examinations following administration of OPTISON.
Overall safety profile in terms of 12-lead electrocardiograms (ECGs) following administration of OPTISON.
Descriptive statistics will be used to describe the observed values and change from baseline for ECG intervals (heart rate, PR, RR, QRS, QT, QTcB [Bazett], QTcF [Fridericia]).
Left ventricular opacification (LVO) assessed by visual peak contrast intensity following intravenous administration of OPTISON at various doses.
Left ventricular opacification (LVO) assessed by peak LV contrast filling following intravenous administration of OPTISON at various doses.
Duration of contrast enhancement following intravenous administration of OPTISON at various doses.

Full Information

First Posted
October 31, 2018
Last Updated
June 22, 2023
Sponsor
GE Healthcare
Collaborators
Laboratory Corporation of America
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1. Study Identification

Unique Protocol Identification Number
NCT03740997
Brief Title
Study to Determine Dosage of OPTISON in Pediatric Patients
Official Title
A Phase 4, Open-Label, Non-randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of OPTISON™ for Contrast- Enhanced Echocardiography in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
Laboratory Corporation of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study to determine the safety and appropriate dosage of OPTISON in pediatric patients since OPTISON has been tested in adult patients only during the clinical development

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Study to Determine Dosage of OPTISON in Children Between ≥9 and <18 Years of Age Weighing ≥20 kg
Keywords
Contrast-enhanced echocardiography (CE-ECHO), Transthoracic echocardiogram, Child, Left ventricular opacification (LVO), Left ventricular ejection fraction (LVEF), Left ventricular endocardial border delineation (LV EBD)

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with body weight ≥20 to ≤28 kg
Arm Type
Experimental
Arm Description
In children weighing ≥20 to ≤28 kg, 0.1 or 0.2 mL of OPTISON per injection will be given in ascending order. The cumulative dose will not exceed 1.0 mL.
Arm Title
Patients with body weight >28 to ≤40 kg
Arm Type
Experimental
Arm Description
If children weigh >28-≤40 kg, 0.2 or 0.3 mL of OPTISON per injection will be administered in ascending order with total dose not to exceed 1.5 mL.
Arm Title
Patients with body weight >40 kg
Arm Type
Experimental
Arm Description
For children whose weight is >40 kg, 0.2 or 0.4 mL of OPTISON per injection will be administered in ascending order with total dose not to exceed 1.8 mL.
Intervention Type
Drug
Intervention Name(s)
Optison
Other Intervention Name(s)
Perflutren Microspheres Injectable Suspension, USP
Intervention Description
Optison is administered intravenously
Primary Outcome Measure Information:
Title
Visualization of the 12 segments of the left ventricle wall in standard apical 4-chamber and 2-chamber views measured by the qualitative endocardial border delineation (EBD) visualization scale.
Description
A qualitative score will be assigned to each left ventricle (LV) segment: 0 = no visualization of the LV endocardial border = poor visualization = fair visualization = good/optimal visualization
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Overall safety profile in terms of occurrence of adverse events (AEs) following administration of OPTISON.
Time Frame
72 hours
Title
Overall safety profile in terms of changes in measurements of systolic and diastolic blood pressure following administration of OPTISON.
Time Frame
72 hours
Title
Overall safety profile in terms of changes in heart rate following administration of OPTISON.
Time Frame
72 hours
Title
Overall safety profile in terms of changes in respiratory rate following administration of OPTISON.
Time Frame
72 hours
Title
Overall safety profile in terms of changes in pulse oximetry following administration of OPTISON.
Time Frame
72 hours
Title
Overall safety profile in terms of arterial oxygen saturation (SaO2) following administration of OPTISON.
Time Frame
72 hours
Title
Overall safety profile in terms of physical examinations following administration of OPTISON.
Time Frame
72 hours
Title
Overall safety profile in terms of 12-lead electrocardiograms (ECGs) following administration of OPTISON.
Description
Descriptive statistics will be used to describe the observed values and change from baseline for ECG intervals (heart rate, PR, RR, QRS, QT, QTcB [Bazett], QTcF [Fridericia]).
Time Frame
72 hours
Title
Left ventricular opacification (LVO) assessed by visual peak contrast intensity following intravenous administration of OPTISON at various doses.
Time Frame
72 hours
Title
Left ventricular opacification (LVO) assessed by peak LV contrast filling following intravenous administration of OPTISON at various doses.
Time Frame
72 hours
Title
Duration of contrast enhancement following intravenous administration of OPTISON at various doses.
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Comparison of diagnostic confidence of LV EBD and wall motion between non-contrast and OPTISON-enhanced echocardiography at various doses.
Time Frame
72 hours
Title
Comparison of diagnostic confidence in the evaluation of LVEF between non-contrast and OPTISON-enhanced echocardiography.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject is between ≥9 and <18 years of age and weighs ≥20 kg. The subject is clinically indicated to undergo a transthoracic echocardiogram. The subject has a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized. The subject is able to comply with study procedures. A parent or legal guardian of the subject has signed and dated an informed consent form. Exclusion Criteria: The subject was previously enrolled in this study. The subject has received an investigational medicinal product within 30 days before or is scheduled to receive one from time of entry into this study until completion of the follow-up period proposed for this study. The subject has a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin. The subject has pulmonary hypertension or unstable cardiopulmonary conditions. The subject has severe liver disease based on medical history. The subject had a recent (<6 months) neurological event. The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Tranquart, M.D., Ph.D.
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
MCG Health, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Cohen Children's Medical Center of New York
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Study to Determine Dosage of OPTISON in Pediatric Patients

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