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Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
NCT03740997 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DRUG Optison
Study Locations (8)
Arizona
- Phoenix Children's Hospital — Phoenix
California
- Children's Hospital Los Angeles — Los Angeles
Georgia
- MCG Health, Inc. — Augusta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Maryland
- Johns Hopkins University School of Medicine — Baltimore
New York
- Cohen Children's Medical Center of New York — Lake Success
Ohio
- Cleveland Clinic Foundation — Cleveland
Texas
- Baylor College of Medicine — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03740997
The ClinicalTrials.gov registry entry for NCT03740997 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 19 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Transthoracic Echocardiography appearing as the primary indexed condition, and to 1 intervention — of which Optison is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03740997 reports 8 study locations spanning 8 distinct geographic areas — top geographies include Arizona, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03740997 about?
NCT03740997 is a clinical study titled "Study to Determine Safety and Dosage of OPTISON in Pediatric Participants". 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
What is the current status of trial NCT03740997?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 39 participants. The study started on 2020-12-01. Estimated completion is 2023-03-30.
What conditions does trial NCT03740997 study?
This clinical trial studies the following conditions: Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03740997?
The interventions under investigation include: Optison (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03740997?
This trial is sponsored by GE Healthcare, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03740997 being conducted?
This trial has 8 study locations across Arizona, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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