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Gadofosveset (EPIX/Schering).

Aamer Farooki1, Vamsidhar Narra, Jeffrey Brown

  • 1Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 South Kingshighway, Saint Louis, MO 63110, USA.

Current Opinion in Investigational Drugs (London, England : 2000)
|October 27, 2004
PubMed
Summary

This article reviews the development of gadofosveset, a specialized contrast agent designed to improve magnetic resonance imaging of blood vessels and circulation in patients suffering from peripheral vascular disease.

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Area of Science:

  • Diagnostic imaging within gadofosveset clinical development
  • Vascular medicine and radiology

Background:

No prior work had resolved the optimal contrast agent for high-resolution vascular imaging in patients with peripheral vascular disease. That uncertainty drove the development of specialized molecules designed to remain within the circulatory system. Prior research has shown that standard agents often diffuse rapidly into surrounding tissues, limiting their utility for prolonged vascular assessment. This gap motivated the creation of albumin-binding compounds that extend the duration of signal enhancement during scanning. Researchers sought to overcome the limitations of extracellular fluid agents by targeting specific plasma proteins. Such an approach aims to improve the visualization of complex arterial networks during diagnostic procedures. The medical community required a more stable intravascular marker to enhance clinical decision-making for patients with restricted blood flow. This review examines the progress of a specific gadolinium-based agent intended to address these diagnostic challenges.

Purpose Of The Study:

Keywords:
contrast agentsvascular diseasegadolinium-based imagingclinical development

Frequently Asked Questions

The researchers propose that the agent binds to albumin, which keeps it within the bloodstream longer than standard extracellular contrast agents. This mechanism allows for more detailed visualization of blood vessels and flow patterns in patients with peripheral vascular disease.

Gadofosveset is a gadolinium-based compound. Unlike conventional agents that quickly exit the vessels, this molecule utilizes albumin-binding properties to maintain an intravascular presence during magnetic resonance imaging procedures.

The authors indicate that the intravascular retention is necessary for the clear imaging of blood vessels. By remaining in the circulation, the agent provides a sustained signal that is required for accurate assessment of vascular anatomy.

The researchers utilize clinical development data and regulatory filing information to evaluate the agent. This evidence includes the submission of a Marketing Authorization Application in the European Union and anticipated approval timelines in the United States.

Related Experiment Videos

The aim of this study is to describe the development of gadofosveset for diagnostic imaging applications. Researchers sought to address the need for improved visualization of blood vessels in patients with peripheral vascular disease. This work explores the rationale behind creating an albumin-binding contrast agent. The authors investigate the specific clinical goals set by the developers, EPIX Medical and Schering. They examine the progress made toward regulatory approval in both the United States and the European Union. This study provides a summary of the agent's intended use in clinical practice. The motivation for this research stems from the requirement for more effective tools in vascular radiology. The authors outline the strategic development path of this intravascular magnetic resonance imaging contrast agent.

Main Methods:

Review approach involved synthesizing clinical development milestones for the specified contrast agent. The authors examined corporate reports from EPIX Medical and Schering regarding the compound. This analysis focused on the regulatory status and intended clinical applications of the molecule. The researchers evaluated the timeline of submissions for market authorization in different regions. They assessed the potential utility of the agent for vascular diagnostic procedures. This review approach integrated data from multiple phases of the development lifecycle. The investigators scrutinized the properties of the agent to understand its role in imaging blood flow. This systematic examination provided a comprehensive overview of the agent's current standing.

Main Results:

Key findings from the literature indicate that the agent is being developed for the imaging of blood vessels and blood flow. The researchers report that the compound is specifically targeted for patients with peripheral vascular disease. Data shows that Schering filed a Marketing Authorization Application in the European Union in June 2004. The authors note that United States approval was anticipated by October 2004. This gadolinium-based agent functions by binding to albumin to remain within the intravascular space. The literature confirms that the development is a collaborative effort between EPIX Medical and Schering. Findings suggest the agent provides a specialized approach to magnetic resonance imaging. The results highlight the transition of this technology toward clinical availability during the mid-2000s.

Conclusions:

The authors suggest that this albumin-binding agent offers a potential advancement for imaging blood vessels. Synthesis and implications indicate that the compound may improve the detection of flow abnormalities in peripheral vascular disease. Clinical trials and regulatory filings demonstrate the ongoing effort to bring this technology to patient care. The researchers propose that the intravascular nature of the agent provides a distinct advantage over traditional extracellular contrast media. Evidence from the literature supports the continued evaluation of this molecule for diagnostic applications. The authors note that the timing of regulatory submissions reflects the anticipated clinical utility of the product. Future assessments will determine the long-term impact of this imaging tool on patient outcomes. These findings highlight the importance of targeted contrast agents in modern diagnostic radiology.

The authors report on the progress of the agent for peripheral vascular disease. This measurement of development includes the filing of an MAA in June 2004 and the anticipated US approval in October 2004.

The researchers propose that this agent could improve the imaging of blood vessels. They suggest that its use may assist in the diagnostic evaluation of patients suffering from peripheral vascular disease.