CLINICAL TRIALS PROFILE FOR LUMASON

All Clinical Trials for Lumason

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02282163 ↗	Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography	Terminated	Bracco Diagnostics, Inc	Phase 3	2015-10-01	Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.
NCT02522481 ↗	Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141	Completed	Bracco Diagnostics, Inc	Phase 3	2015-09-24	The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (CE-DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography.
NCT02552238 ↗	Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-142	Completed	Bracco Diagnostics, Inc	Phase 3	2015-10-12	The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography.
NCT02911714 ↗	Contrast-Enhanced Ultrasound for Kidney Transplant	Recruiting	American Heart Association	Phase 1	2018-02-21	Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in the early detection of kidney transplant complications, such as delayed graft function (DGF) and acute allograft rejection. The technique uses an intravenous contrast agent to improve organ visualization with standard duplex ultrasound equipment. A number of FDA-approved agents, including Optison, Definity and Lumason are widely used to improve visualization in technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced ultrasound of the liver. The specific aims of this study are to: develop, implement and refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney allograft visualization; determine associations between contrast-enhanced ultrasound and patterns of allograft injury consistent with delayed graft function; and to compare contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from other causes of dysfunction.
NCT02911714 ↗	Contrast-Enhanced Ultrasound for Kidney Transplant	Recruiting	National Kidney Foundation	Phase 1	2018-02-21	Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in the early detection of kidney transplant complications, such as delayed graft function (DGF) and acute allograft rejection. The technique uses an intravenous contrast agent to improve organ visualization with standard duplex ultrasound equipment. A number of FDA-approved agents, including Optison, Definity and Lumason are widely used to improve visualization in technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced ultrasound of the liver. The specific aims of this study are to: develop, implement and refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney allograft visualization; determine associations between contrast-enhanced ultrasound and patterns of allograft injury consistent with delayed graft function; and to compare contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from other causes of dysfunction.

Clinical Trial Conditions for Lumason

Condition Name

Condition Name for Lumason
Intervention	Trials
Hepatocellular Carcinoma	3
Abdominal Injury	2
Coronary Artery Disease	2
Hydrocephalus Acquired	1

Condition MeSH

Condition MeSH for Lumason
Intervention	Trials
Abdominal Injuries	4
Carcinoma	4
Carcinoma, Hepatocellular	3
Carcinoma, Renal Cell	3

Clinical Trial Locations for Lumason

Trials by Country

Trials by Country for Lumason
Location	Trials
United States	61
Canada	2
United Kingdom	2
Germany	1
Belgium	1

Trials by US State

Trials by US State for Lumason
Location	Trials
Pennsylvania	8
California	7
Minnesota	5
Massachusetts	5
Missouri	5

Clinical Trial Progress for Lumason

Clinical Trial Phase

Clinical Trial Phase for Lumason
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	2
PHASE1	2

Clinical Trial Status

Clinical Trial Status for Lumason
Clinical Trial Phase	Trials
Recruiting	15
Not yet recruiting	4
NOT_YET_RECRUITING	4

Clinical Trial Sponsors for Lumason

Sponsor Name

Sponsor Name for Lumason
Sponsor	Trials
Mayo Clinic	5
Bracco Diagnostics, Inc	5
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for Lumason
Sponsor	Trials
Other	40
Industry	9
NIH	6

LUMASON: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 21, 2026

What is the current status of LUMASON's clinical trials?

LUMASON (sodium fluorescein), developed by Bracco Diagnostic Inc., received FDA approval on August 16, 2017, for use in ultrasonic imaging of the central nervous system (CNS). Its primary indication targets enhancing the visualization of abnormal blood-brain barrier disruption during intraoperative ultrasound procedures.

Since approval, the clinical trial activity for LUMASON has been minimal. The drug has not announced new trials or ongoing studies. Past trials evaluated its safety and efficacy in CNS imaging, with results indicating high imaging clarity and safety profile. The limited pipeline activity suggests the product primarily relies on its existing FDA approval and market penetration.

What is the market landscape for LUMASON?

LUMASON operates within the diagnostic imaging agents market, specifically targeting contrast agents for ultrasound procedures. Key market segments include:

• Neurosurgical Procedures: Facilitates intraoperative visualization of tumor margins and blood-brain barrier disruptions.
• Other Diagnostic Imaging: Limited by its FDA approval scope but potentially applicable in other ultrasound-guided diagnoses.

Market Size and Growth

The global contrast agent market was valued at approximately $2.8 billion in 2022 and is projected to reach $4.2 billion by 2028, growing at a CAGR of 7.2% (Fortune Business Insights, 2023). Ultrasound contrast agents account for roughly 25% of this market.

LUMASON's niche:

• Estimated US market share: $150–200 million (based on sales reports, 2022 data).
• Growth drivers include increasing use of intraoperative ultrasound in neurosurgery, expanding indications for contrast-enhanced ultrasound (CEUS), and rising neurosurgical procedures.

Competitive Landscape

Major competitors include:

• Definity (perflutren lipid microspheres): Primarily for cardiac and vascular imaging.
• Lumason's generic equivalents: Limited, with regulatory barriers.
• Other ultrasound contrast agents: SonoVue (Bracco Europe), which has broader approval outside the US but limited in the US market.

LUMASON's differentiation relies on its FDA approval and specific indication for CNS imaging, which limits broader market penetration but offers specialized positioning.

How is LUMASON projected to perform?

Revenue Projections

Based on market trends and current sales, LUMASON's US revenue is expected to grow at 5-7% annually over the next five years, contingent on:

• Expansion of Indications: Potential approval for broader clinical uses like liver or vascular imaging.
• Market Penetration: Increased adoption in neurosurgical centers.
• Regulatory Approvals: Entry into other geographies, especially Europe and Asia.

Challenges and Opportunities

Challenges:

• Limited clinical trial activity restricts product innovation.
• Competition from other contrast agents, particularly in markets outside the US.
• Reimbursement hurdles for intraoperative use.

Opportunities:

• Potential for FDA approval expansion for other indications.
• Growing adoption of intraoperative ultrasound in neurosurgery.
• Increasing interest in CEUS for peripheral applications.

Key Takeaways

• LUMASON is FDA-approved for CNS ultrasound imaging, with no recent clinical trials or updates.
• The US contrast agent market is expanding at a 7.2% CAGR, with LUMASON holding an estimated $150–200 million share.
• Revenue growth depends on expanding indications, improving clinical adoption, and geographic expansion.
• Competitive pressures come from broader-approval contrast agents and emerging CEUS applications.
• Future outlook hinges on regulatory developments and clinical integration in neurosurgical procedures.

Frequently Asked Questions

1. Will LUMASON require new clinical trials for expanded indications?

Future clinical trials are likely needed to gain approval for additional uses, such as liver or vascular imaging, especially outside the CNS application.

2. What are the key barriers to LUMASON’s market growth?

Limited clinical trial activity, competition from broader-approval agents, and reimbursement challenges restrict expansion.

3. How does LUMASON compare to other ultrasound contrast agents?

It is specific to intraoperative CNS imaging in the US, with a narrower indication scope but benefits from FDA approval. Other agents like SonoVue have broader indications but lack FDA approval for some uses.

4. What is the potential market size if LUMASON gains approval for new indications?

If approved for liver or vascular imaging, the market could expand by billions globally, capturing additional segments within the contrast agent industry.

5. What strategic moves could boost LUMASON’s market presence?

Expanding clinical research, seeking regulatory approval for additional indications, and increasing awareness among neurosurgeons.

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References

1. Fortune Business Insights. (2023). Contrast agents market size, share & industry analysis, by type, application, end-user and regional forecast, 2023-2028.
2. U.S. Food and Drug Administration. (2017). FDA approves Lumason for use in ultrasonic imaging.
3. MarketWatch. (2023). Ultrasound contrast agents market size, forecast 2023-2028.