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Ablavar (Gadofosveset Trisodium) - Summary

 
 



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
  • 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 (5.1) ]
 

ABLAVAR SUMMARY

Ablavar (gadofosveset trisodium) Injection is a sterile, nonpyrogenic, formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate derivative with a diphenylcyclohexylphosphate group. Each mL of Ablavar Injection contains 244 mg of gadofosveset trisodium (0.25 mmol), 0.268 mg of fosveset, and water for injection.

Ablavar 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 all Ablavar indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ablavar (Gadofosveset)

IgG4 Cholangiopathy: A Diagnostic and Therapeutic Challenge
Source: Medscape Gastroenterology Headlines [2014.07.15]
This systemic inflammatory disorder, which occurs most often in older men, can be tricky to diagnose and even harder to effectively treat.
Medscape Gastroenterology

Rollout strategy for diagnostic test in India may impact TB
Source: Medical Devices / Diagnostics News From Medical News Today [2014.07.15]
Xpert MTB/RIF, a recently implemented tuberculosis (TB) test, has the potential to control the TB epidemic in India, but only if the current, narrow, implementation strategy is replaced by a more...

5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference, October 27-29, Arlington, Virginia
Source: Conferences News From Medical News Today [2014.06.30]
New Speakers, Additional Learning Opportunities Available at the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics ConferenceThe most popular meeting for clinical and...

Researchers review the effectiveness of rapid diagnostic tests in diagnosing patients with visceral leishmaniasis
Source: Tropical Diseases News From Medical News Today [2014.06.24]
Researchers from the Cochrane Infectious Disease Group, co-ordinated through the editorial base in LSTM, conducted an independent review into the effectiveness of rapid diagnostic tests in diagnosing...

Low-dose computed tomography screening shows improved diagnostic performance
Source: Lung Cancer News From Medical News Today [2014.06.17]
Investigators of the COSMOS (Continuous Observation of SMOking Subjects) study show good compliance and patient survival outcomes using a 5-year low-dose computed tomography (LDCT) screening protocol...

more news >>

Published Studies Related to Ablavar (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.

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Clinical Trials Related to Ablavar (Gadofosveset)

LMI - Ablavar - 401 - Study of Incidence of Nephrogenic Systemic Fibrosis(NSF) in Kidney Disease Patients Undergoing MRI With Ablavar [Not yet recruiting]
Study Design:

In this phase 4 study, all patients will receive 1 dose of Ablavar as part of an MRI examination in their routine clinical management.

A standardized NSF questionnaire will be administered to the patient at various time points

post-dose. At 1 year and 2 years (+1 or - 1 month) patients will return to the clinic for a

limited examination for skin abnormalities and formal review of signs and symptoms suggestive of NSF.

Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants [Recruiting]
The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.

Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI) [Recruiting]
Patients with chronic liver disease are at high risk of developing liver scarring (fibrosis), with ultimate risks of cirrhosis and liver cancer that may require liver transplant. The investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI) techniques (MR diffusion, perfusion and elastography) to assess the degree of liver damage in patients with chronic liver disease. These techniques combined could reach high diagnostic performance for detection of liver fibrosis; and could decrease the number of liver biopsies, which have risks and sample only a small portion of the liver.

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.

Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer [Recruiting]

more trials >>


Page last updated: 2014-07-15

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