WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any re-administration [ see Warnings and Precautions ]
VASOVIST (gadofosveset trisodium) Injection is a sterile, nonpyrogenic, formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate derivative with a diphenylcyclohexylphosphate group.
VASOVIST is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease [ see Clinical Studies ] .
Published Studies Related to Vasovist (Gadofosveset)
Contrast-enhanced whole-heart MR coronary angiography at 3.0 T using the intravascular contrast agent gadofosveset. [2009.07]
OBJECTIVES: The purpose of this study was to compare contrast-enhanced (CE) whole-heart coronary magnetic resonance angiography (MRA) at 3.0 T using gadofosveset to noncontrast-enhanced steady-state free precession (SSFP) coronary MRA at 1.5 T... CONCLUSIONS: CE whole-heart coronary MRA at 3.0 T demonstrated higher overall CNR between coronary blood and myocardium and an improved image quality of the distal coronary segments compared with noncontrast-enhanced SSFP coronary MRA at 1.5 T.
Safety and efficacy of gadofosveset-enhanced MR angiography for evaluation of pedal arterial disease: multicenter comparative phase 3 study. [2008.01]
CONCLUSION: Because of markedly better efficacy than no contrast agent and a minimal and transient side-effect profile, 0.03 mmol/kg of gadofosveset was found safe and effective for MR angiography of patients with pedal arterial disease.
Contrast-enhanced MRA of the renal and aorto-iliac-femoral arteries: comparison of gadobenate dimeglumine and gadofosveset trisodium. [2011.02]
RATIONALE AND OBJECTIVES: Dedicated contrast agents are now available for contrast-enhanced magnetic resonance angiography (CE-MRA). This study retrospectively compares the safety and diagnostic performance data from Phase III regulatory trials performed to evaluate gadobenate dimeglumine (MultiHance((R))) and gadofosveset trisodium (Vasovist(R))) for renal and peripheral CE-MRA... CONCLUSION: The diagnostic performance of CE-MRA for the detection of significant steno-occlusive disease is similar with gadofosveset and gadobenate dimeglumine although the rate of adverse events appears higher with gadofosveset. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.
CMR assessment of endothelial damage and angiogenesis in porcine coronary arteries using gadofosveset. [2011.01.26]
CONCLUSION: Contrast enhanced coronary CMR with gadofosveset can detect experimentally induced endothelial damage and angiogenesis in the porcine coronary artery wall.
Diffusion magnetic resonance imaging with gadofosveset trisodium as a negative contrast agent for lymph node metastases assessment. [2011.01]
PURPOSE: The aim of this study was to assess the feasibility of using intravenously administered gadofosveset trisodium as a negative contrast agent for lymph node (LN) assessment with diffusion-weighted imaging (DWI) using a VX2 tumor model in rabbits... CONCLUSION: The SI of metastatic LNs at DWI is less suppressed than that of nonmetastatic LNs after the intravenous administration of gadofosveset trisodium. Therefore, intravenously administered gadofosveset trisodium shows promise for use as a negative contrast agent for discriminating metastatic from nonmetastatic LNs at DWI.
Clinical Trials Related to Vasovist (Gadofosveset)
Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease [Terminated]
This study aims at investigating the diagnostic accuracy of magnetic resonance angiography
using the contrast agent Vasovist« in the detection of relevant vascular narrowing of the
lower extremity. Patients who have been scheduled for intra-arterial conventional
angiography are eligible for this trial.
Improved Diagnosis of Congenital Heart Disease by Magnetic Resonance Imaging Using Vasovist [Recruiting]
Magnetic Resonance Imaging (MRI) is an effective and radiation free method of diagnosing
Congenital Heart Disease (CHD). MRI works by taking images of the anatomy and physiology.
These images also provide information on the hearts function and blood flow. The clarity of
these images is enhanced by the use of contrast agents (dyes). However these agents only
stay in the blood vessels for a short time and therefore limit the time in which the better
quality images can be obtained. This study aims to determine whether MRI using Vasovist (a
dye that stays in the vessels for a prolonged period of time) can improve the diagnosis of
Congenital Heart Disease (CHD) by allowing more areas to be imaged and the improved
assessment of various parameters (anatomy, volumes, flow) as well as vastly improving image
Comparison Study of Vasovist´┐Ż Magnetic Resonance Angiography (MRA) and an MRA With a Conventional Extracellular Contrast Agent With X-ray Angiography in Patients With Peripheral Artery Disease [Completed]
The particular aim of this study is the comparison of the diagnostic results of MRA images
upon application of Vasovist (gadofosveset), a contrast agent not yet available on the
market, with the MRA images upon application of a conventional extracellular contrast agent.
A catheter angiography, which will be performed as a routine diagnostic procedure for
vascular diseases, will serve as an evaluation standard.
Gadofosveset for Axillary Staging in Breast Cancer Patients [Completed]
The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared
to current nodal staging methods.
The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged
nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will
be regarded as the golden standard for nodal involvement.
Nodal Staging in Breast Cancer With MRL [Recruiting]
The aim of this study is to examine the diagnostic performance of gadofosveset enhanced
magnetic resonance imaging lymphography (MRL).
The diagnostic performance of MRL will be determined on the basis of a node-to-node matching
of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel
lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the
golden standard for nodal involvement.