Phase 4
N=39
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
Transthoracic Echocardiography · Suspected or Known Structural or Functional Cardiac Abnormality
Bottom Line
View on ClinicalTrials.gov: NCT03740997 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Mean Total Visualization Score of Qualitative Endocardial Border Delineation (EBD) of the 12 Segments of the Left Ventricle (LV) Wall in Standard Apical 4-chamber (A4C) and Apical 2-chamber (A2C) — 15.9; 10.0; 31.3; 26.6 score on a scale — p=0.0008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Optison (Drug)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Total Visualization Score of Qualitative Endocardial Border Delineation (EBD) of the 12 Segments of the Left Ventricle (LV) Wall in Standard Apical 4-chamber (A4C) and Apical 2-chamber (A2C) |
15.9; 10.0; 31.3; 26.6; 35.1; 28.6 | 0.0008 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
4; 9 | — |
| SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure |
-3.3; -4.6; -4.8; -3.8; -2.8; -2.5 | — |
| SECONDARY Change From Baseline in Heart Rate |
-3.1; -4.9; -3.8; -2.1 | — |
| SECONDARY Change From Baseline in Respiratory Rate |
-0.8; -0.2; -0.8; -1.5 | — |
| SECONDARY Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry |
0.0; 0.1; -0.5; -0.2 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormality in Physical Examination Findings |
0; 0 | — |
| SECONDARY Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters |
-2.5; -2.0; -3.0; -0.1; -0.8; -0.2 | — |
| SECONDARY Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity |
0; 2; 0; 0; 2; 8 | — |
| SECONDARY Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling |
0; 2; 0; 1; 1; 1 | — |
| SECONDARY Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber |
0; 3; 1; 2; 3; 5 | — |
| SECONDARY Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images |
2; 10; 4; 9; 1; 4 | — |
| SECONDARY Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography |
4; 11; 3; 11; 0; 1 | — |
Summary
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development
Eligibility Criteria
Inclusion Criteria
- The participant was between ≥9 and <18 years of age and weighs ≥20 kg.
- The participant was clinically indicated to undergo a transthoracic echocardiogram.
- The participant had a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized.
- The participant was able to comply with study procedures.
- A parent or legal guardian of the participant had signed and dated an informed consent form.
- Post-menarchal female participants must have had a negative urine pregnancy test at screening and at pre-dose on the day of OPTISON administration.
- Post-menarchal female participants must have been practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study
Exclusion Criteria
- The participant was previously enrolled in this study.
- The participant 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 participant had a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin.
- The participant had pulmonary hypertension or unstable cardiopulmonary conditions.
- The participant had severe liver disease based on medical history.
- The participant had a recent (<6 months) neurological event.
- The participant presented 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 participant or other reason that in the judgment of the investigator makes the participant unsuitable for participation in the study.
- The participant was a pregnant or lactating female, or was a female of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test was also required).
Data sourced from ClinicalTrials.gov (NCT03740997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.