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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 20 May 2025

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At a glance

  • Drugs Perflutren (Primary)
  • Indications Left ventricular dysfunction
  • Focus Diagnostic use
  • Sponsors GE Healthcare

Most Recent Events

  • 13 May 2025 According to a GE HealthCare media release, the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) ultrasound enhancing agent (UEA).
  • 08 Apr 2024 Results (n=37) assessing Efficacy of Intravenous Administration of Optison for Contrast-Enhanced Echocardiography in Pediatric Patients presented at the 73rd Annual Scientific Session of the American College of Cardiology
  • 22 Jun 2023 Status changed from recruiting to completed.

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