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Lumason® Infusion vs. Bolus Administrations
NCT06400004 · View on ClinicalTrials.gov ↗
Study Summary
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
Conditions Studied
Interventions
- DRUG Lumason
- DRUG Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
Study Locations (6)
Texas
- University of Texas Medical Branch — Galveston
- Vital Heart and Vein — Humble
California
- Interventional Cardiology Medical Group — West Hills
Georgia
- Piedmont Heart Institute — Atlanta
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Oregon
- Oregon Health and Sciences University — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06400004
The ClinicalTrials.gov registry entry for NCT06400004 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bracco Diagnostics, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heart Diseases appearing as the primary indexed condition, and to 2 interventions — of which Lumason 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: NCT06400004 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, 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 NCT06400004 about?
NCT06400004 is a clinical study titled "Lumason® Infusion vs. Bolus Administrations". A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
What is the current status of trial NCT06400004?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2024-07-10. Estimated completion is 2026-12-31.
What conditions does trial NCT06400004 study?
This clinical trial studies the following conditions: Heart Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06400004?
The interventions under investigation include: Lumason (DRUG), Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06400004?
This trial is sponsored by Bracco Diagnostics, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06400004 being conducted?
This trial has 6 study locations across California, Georgia, Massachusetts, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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