CLINICAL TRIALS PROFILE FOR GADOFOSVESET TRISODIUM

All Clinical Trials for Gadofosveset Trisodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01135316 ↗	Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR	Completed	Lantheus Medical Imaging		2009-10-01	Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months.
NCT01165892 ↗	Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)	Completed	Lantheus Medical Imaging		2011-07-01	The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).
NCT01165892 ↗	Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)	Completed	Washington University School of Medicine		2011-07-01	The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).
NCT01655043 ↗	Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI	Completed	Astellas Pharma Global Development, Inc.	Phase 2	2012-09-01	Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery disease that is considered most accurate is coronary angiography however it involves risk and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi qualitative analysis of the myocardial perfusion images. In this proposal the investigators will develop a means to calculate Coronary Flow Reserve (CFR) using the MRI. the investigators approach has the potential to reduce mortality from myocardial infarction by effecting a change in the patient management paradigm. Absolute quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with more accuracy than the semi-quantitative or qualitative analysis of perfusion images. Measurement of Coronary Flow Reserve is important for the following reasons: decrease of coronary flow reserve has been identified as a first effect of CAD; it provides an objective measure of treatment efficacy. The purpose of this study is to compare images from nuclear stress test and/or coronary angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary artery disease calculating myocardial blood flow using a novel MRI technique combined to an extracellular Gadolinium-based contrast agent and stressor agent
NCT01655043 ↗	Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI	Completed	Northwestern University	Phase 2	2012-09-01	Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery disease that is considered most accurate is coronary angiography however it involves risk and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi qualitative analysis of the myocardial perfusion images. In this proposal the investigators will develop a means to calculate Coronary Flow Reserve (CFR) using the MRI. the investigators approach has the potential to reduce mortality from myocardial infarction by effecting a change in the patient management paradigm. Absolute quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with more accuracy than the semi-quantitative or qualitative analysis of perfusion images. Measurement of Coronary Flow Reserve is important for the following reasons: decrease of coronary flow reserve has been identified as a first effect of CAD; it provides an objective measure of treatment efficacy. The purpose of this study is to compare images from nuclear stress test and/or coronary angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary artery disease calculating myocardial blood flow using a novel MRI technique combined to an extracellular Gadolinium-based contrast agent and stressor agent
NCT01721785 ↗	Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer	Completed	Dutch Cancer Society		2012-10-01	The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.
NCT01721785 ↗	Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer	Completed	Maastricht University Medical Center		2012-10-01	The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.

Clinical Trial Conditions for Gadofosveset Trisodium

Condition Name

Condition Name for Gadofosveset Trisodium
Intervention	Trials
Magnetic Resonance Imaging	1
Myocardial Ischemia	1
Neoplasms Staging	1
Nephrogenic Systemic Fibrosis	1

Condition MeSH

Condition MeSH for Gadofosveset Trisodium
Intervention	Trials
Nephrogenic Fibrosing Dermopathy	1
Neoplasms	1
Kidney Diseases	1
Myocardial Ischemia	1

Clinical Trial Locations for Gadofosveset Trisodium

Trials by Country

Trials by Country for Gadofosveset Trisodium
Location	Trials
Netherlands	5
United States	4

Trials by US State

Trials by US State for Gadofosveset Trisodium
Location	Trials
California	1
Illinois	1
North Carolina	1
New York	1

Clinical Trial Progress for Gadofosveset Trisodium

Clinical Trial Phase

Clinical Trial Phase for Gadofosveset Trisodium
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Gadofosveset Trisodium
Clinical Trial Phase	Trials
Completed	4
Recruiting	1
Withdrawn	1

Clinical Trial Sponsors for Gadofosveset Trisodium

Sponsor Name

Sponsor Name for Gadofosveset Trisodium
Sponsor	Trials
Lantheus Medical Imaging	2
Maastricht University Medical Center	2
Washington University School of Medicine	1

Sponsor Type

Sponsor Type for Gadofosveset Trisodium
Sponsor	Trials
Other	6
Industry	3

Gadofosveset Trisodium: Clinical-Trial Status, Market Read-Through, and Projection

Last updated: April 28, 2026

What clinical data is gadofosveset trisodium tied to?

Gadofosveset trisodium is a gadolinium-based contrast agent (GBCA) designed for intravascular contrast using reversible albumin binding. Across pivotal development, the program is anchored to cardiovascular MRI use cases, with the closest “commercial-shaping” endpoints concentrated in contrast-enhanced imaging performance for cardiac structure and function and lesion detection.

Pivotal development focus areas

• Cardiac MRI perfusion and vascular imaging (albumin-binding GBCA strategy).
• Lesion characterization and vascular visualization in approved or late-stage indications across geographies.

Regulatory shape reflected in trial endpoints

Clinical studies historically emphasized:

• Image quality and contrast persistence in blood pool imaging.
• Diagnostic performance versus standard-of-care GBCAs.
• Safety profile consistent with other GBCAs (notably gadolinium exposure and related risk management practices).

What is the current clinical-trials reality (and what does it imply for new studies)?

There is no ongoing, late-stage interventional clinical-trial lifecycle that would normally support a near-term expansion of indication scope or a fresh regulatory filing in major jurisdictions. The practical implication for investors and R&D planners is straightforward: the development risk profile is mostly “post-approval execution,” not “new clinical validation.”

What market does gadofosveset trisodium address?

The commercial market for gadofosveset is the intersection of:

• Gadolinium-based contrast agents (used across MRI).
• Cardiac and vascular MRI (a smaller, procedure-intense segment where blood-pool persistence matters).

Where it can win commercially

Gadofosveset’s value proposition in the market is tied to:

• Sustained intravascular contrast (blood pool effect).
• Potential workflow efficiency and image-quality advantages in cardiovascular MRI.

Where it faces structural headwinds

• Competitive saturation by multiple MRI contrast agents with broad labeling.
• Hospital purchasing cycles that favor established formularies and supply reliability.
• Limited expansion leverage when uptake does not translate into durable demand growth after launch.

Market analysis: demand drivers vs. substitution risk

Demand drivers

• Growth in MRI utilization and in cardiovascular MRI volumes.
• Preference for agents that improve diagnostic confidence in time-sensitive or motion-prone imaging.

Substitution risk

• Many GBCA products compete on price, availability, and institutional protocols.
• Albumin-binding performance must translate into consistently better clinical outcomes and reproducible image quality in real-world workflows to sustain formulary entrenchment.

Projection: base-case commercialization trajectory

Given the lack of active late-stage development momentum and the nature of GBCA procurement, the most defensible projection is a steady-state, non-expansion trajectory rather than a high-growth recovery narrative.

Projection framework (how the model is built)

For GBCA products without fresh clinical escalation, annual change typically tracks:

• MRI volume growth (macro driver).
• Share retention vs. formulary erosion (micro driver).
• Pricing pressure and tender dynamics (commercial driver).

Base-case outlook

• Sales growth tracks at or below market growth, driven mainly by MRI volume expansion.
• Share trends modestly downward in markets where competing agents are entrenched.
• Geographic scaling is limited unless the product retains or expands hospital access.

Scenario projection (2026 to 2031)

The projection below expresses directionality and planning ranges rather than a single-point forecast.

Scenario	Share trend	Pricing trend	Net market position	2026-2031 outcome
Base case	Slight decline	Mild pressure	Maintains relevance in select cardiology MRI pathways	Low single-digit annual revenue growth
Downside	Material decline	Strong pressure	Loses formulary access as contracts renew	Flat to negative revenue trend
Upside	Stable/incremental gains	Moderate pressure	Retains blood-pool role in cardiovascular MRI	Mid single-digit growth possible if institutional switching occurs

What should business leaders monitor to validate the projection?

Commercial indicators (leading)

• Tender outcomes and contract renewals in cardiac imaging centers.
• Formulary inclusion in major hospital groups and imaging networks.
• Supply continuity (GBCA category is sensitive to vendor constraints).

Clinical indicators (confirming)

• Publication of real-world evidence comparing diagnostic performance and workflow time.
• Evidence of protocol adoption for blood-pool imaging in cardiovascular MRI.

Key implications for R&D planning

For companies evaluating adjacency or platform strategy, gadofosveset’s development arc informs two operational realities:

• Albumin-binding GBCA differentiation must survive formulary substitution to translate into durable value.
• Without new clinical evidence that changes protocols at scale, GBCA commercial outcomes are dominated by procurement economics.

Key Takeaways

• Gadofosveset trisodium is a blood-pool MRI GBCA designed for sustained intravascular contrast, with clinical development centered on cardiovascular imaging performance.
• The current state of the program does not point to active late-stage clinical expansion that would materially change regulatory or indication scope.
• Market growth is most likely to come from MRI volume trends, while substitution risk and tender-driven pricing pressure keep the trajectory constrained.
• Planning should assume a steady-state, share-sensitive commercialization profile rather than a growth-driven reacceleration.

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FAQs

1) What is gadofosveset trisodium used for?

It is used as a gadolinium-based contrast agent for MRI, with development emphasis on intravascular and cardiovascular imaging where blood-pool contrast is clinically valuable.

2) Why does albumin-binding matter for this product category?

Albumin binding increases intravascular residence time, which can improve blood-pool visualization for cardiovascular MRI workflows compared with standard extracellular GBCAs.

3) What most affects gadofosveset’s market performance?

Hospital formulary decisions, tender pricing, and competitive substitution within the GBCA category.

4) Does the clinical pipeline support a near-term indication expansion thesis?

The available program trajectory does not indicate an active late-stage expansion path that would change the near-term commercialization outlook.

5) What would change the projection most?

Substantial real-world evidence driving broad protocol adoption and favorable tender outcomes that preserve or grow hospital share.

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References

[1] FDA. Drug Safety and Availability. (Accessed 2026-04-28). https://www.fda.gov/drugs/drug-safety-and-availability
[2] European Medicines Agency (EMA). Gadolinium-based contrast agents and related safety and risk management guidance. (Accessed 2026-04-28). https://www.ema.europa.eu
[3] NCBI/NIH. Gadofosveset trisodium clinical trial publications and reviews. (Accessed 2026-04-28). https://pubmed.ncbi.nlm.nih.gov