WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
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 readministration (see
MAGNEVIST « (brand of gadopentetate dimeglumine) Injection is the N- methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI).
MAGNEVIST Injection is indicated for the following:
Central Nervous System
MAGNEVIST Injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. MAGNEVIST Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.
MAGNEVIST is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck.
MAGNEVIST Injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart).
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Researchers at Johns Hopkins have evaluated the extent of diagnostic errors in the U.S. They found that such errors account for around 160,000 deaths every year.
Published Studies Related to Magnevist (Gadopentetate)
Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial). [2011.02]
PURPOSE: To intraindividually compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast material-enhanced breast magnetic resonance (MR) imaging by using a prospective, multicenter double-blind, randomized protocol... CONCLUSION: Gadobenate dimeglumine is superior to gadopentetate dimeglumine for breast cancer diagnosis. (c) RSNA, 2010 Clinical trial registration no. NCT00486473 (http://www.clinicaltrials.gov/). Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100968/-/DC1.
Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for MR angiography of peripheral arteries. [2010.06]
PURPOSE: To prospectively compare the image quality and diagnostic performance achieved with doses of gadobenate dimeglumine and gadopentetate dimeglumine of 0.1 mmol per kilogram of body weight in patients undergoing contrast material-enhanced magnetic resonance (MR) angiography of the pelvis, thigh, and lower-leg (excluding foot) for suspected or known peripheral arterial occlusive disease... CONCLUSION: Higher-quality vessel visualization, greater contrast enhancement, fewer technical failures, and improved diagnostic performance are obtained with gadobenate dimeglumine, relative to gadopentetate dimeglumine, when compared intraindividually at 0.1-mmol/kg doses in patients undergoing contrast-enhanced MR angiography for suspected peripheral arterial occlusive disease. Copyright RSNA, 2010
Detection of cerebral metastases on magnetic resonance imaging: intraindividual comparison of gadobutrol with gadopentetate dimeglumine. [2009.10]
CONCLUSION: At equal gadolinium dosage, gadobutrol appears to offer significant advantages over gadopentetate dimeglumine for the visualization of brain metastases, with particular benefit for improving the conspicuity of detected lesions.
Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 tesla. [2009.04]
PURPOSE: To prospectively compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast-enhanced MRI of brain lesions at 3 Tesla (T)... CONCLUSION: Brain lesion depiction at 3T is significantly improved with 0.1 mmol/kg gadobenate dimeglumine.
Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial. [2009.03]
CONCLUSION: This study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol (0.1 mmol/kg body weight) to 0.5 M gadopentetate (0.1 mmol/kg body weight) in the diagnostic assessment of liver lesions with contrast-enhanced MRI. The known excellent safety profile of gadobutrol was confirmed in this clinical trial and is similar to that of gadopentetate.
Clinical Trials Related to Magnevist (Gadopentetate)
Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI [Recruiting]
This research is being done to find out if using the contrast agent MultiHance can be used
to show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial
MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast
material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is
believed that using MultiHance may be able to help doctors tell normal liver cells apart
from active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may
improve the way patients with hepatocellular carcinoma are managed clinically.
We hypothesize that the Multi-Hance contrast material will provide better image definition
of treated liver tumor(s) on MRI imaging in comparison to other commercially available
Gadobutrol Magnevist-controlled Body Study [Recruiting]
The purpose of the study is to look at the safety (what are the side effects) and efficacy
(how well does it work) of gadobutrol when used for taking MR images of the body/extremities
regions. The results of the MRI with gadobutrol injection will be compared to the results
of MR images taken without contrast and with the results of the MR images taken with
Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries [Recruiting]
To compare two gadolinium contrast agents in terms of global paired diagnostic preference
(primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid,
renal/abdominal and peripheral arteries
Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist [Recruiting]
Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist
injection. Subjects will be screened within 48 hours of previously scheduled MRI, those
meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post
MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls
conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.
Safety and Efficacy Evaluation of DOTAREM´┐Ż in MRI of Central Nervous System (CNS) Lesions [Recruiting]
The purpose of this study is to look at the safety (what are the side effects)and efficacy
(how well does it work) of Dotarem« when used in taking images of the brain / spine. The
results will be compared to the results of MRI taken without Dotarem.
Reports of Suspected Magnevist (Gadopentetate) Side Effects
Nephrogenic Systemic Fibrosis (284),
Skin Induration (158),
Mobility Decreased (134),
Skin Tightness (125),
Oedema Peripheral (122),
Emotional Distress (118),
Skin Hypertrophy (110), more >>
Page last updated: 2014-04-16