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 'Adverse Reaction' 
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Adverse Reaction
Any abnormal reaction of a patient to an examination or procedure, like for example claustrophobia or side effects of MRI contrast agents.
A claustrophobic attack is MRI scanner dependent and more rare with an open MRI. An adverse reaction with magnetic resonance imaging contrast medium is very infrequent. In general, adverse reactions increase with the quantity of contrast media (usual dose of paramagnetic contrast agents is 0.1 mmol/kg) and also with the osmolarity of the compound.
Most frequently encountered adverse reactions are heat sensation, dizziness, nausea, hypotension due to vasodilatation, which can progress to hypotensive shock and anaphylactic reactions.
See also MRI Safety, Contrast Enhanced MRI, Breast MRI, and Cardiac MR imaging.
Radiology-tip.comSafety of Contrast Agents,  Anaphylactoid Reaction
Radiology-tip.comUltrasound Contrast Agent Safety
• For this and other aspects of MRI safety see our InfoSheet about MRI Safety.
• Patient-related information is collected in our MRI Patient Information.

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    • Nerve Conductivity
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    • Nephrogenic Systemic Fibrosis
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Further Reading:
Contrast Agents: Safety Profile
  News & More:
Questions and Answers on Gadolinium-Based Contrast Agents
Friday, 9 January 2009   by    
Searchterm 'Adverse Reaction' was also found in the following services: 
Radiology  (12) Open this link in a new windowUltrasound  (5) Open this link in a new window
ABLAVAR™InfoSheet: - Contrast Agents - 
Intro, Overview, 
Types of, 
ABLAVAR™ (formerly named Vasovist™) is a blood pool agent for magnetic resonance angiography (MRA), which opens new medical imaging possibilities in the evaluation of aortoiliac occlusive disease (AIOD) in patients with suspected peripheral vascular disease.
ABLAVAR™ binds reversibly to blood albumin, providing imaging with high spatial resolution up to 1 hour after injection, due to its high relaxivity and to the long lasting increased signal intensity of blood.
As with other contrast media: the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered.
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 less than 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.
See also Cardiovascular Imaging, Adverse Reaction, Molecular Imaging, and MRI Safety.

Drug Information and Specification
NAME OF COMPOUND Diphenylcyclohexyl phosphodiester-Gd-DTPA, gadofosveset trisodium, MS-325
DEVELOPER EPIX Pharmaceuticals, Inc.
CONTRAST EFFECT T1, predominantly positive enhancement
RELAXIVITY 20-45 mmol-1sec-1, Bo=0,47T
OSMOLALITY 825 mOsmol/kg H2O
CONCENTRATION 244 mg/mL, 0.25mmol/mL
DOSAGE 0.12 mL/kg, 0.03 mmol/kg
PREPARATION ready to use
INDICATION Contrast enhanced magnetic resonance angiography

Distribution Information
EU Vasovist® Approved ?
USA, Canada, Australia ABLAVAR™ Approved Lantheus Medical Imaging, Inc.


• View the DATABASE results for 'ABLAVAR™' (3).Open this link in a new window

• View the NEWS results for 'ABLAVAR™' (1).Open this link in a new window.
Further Reading:
Ablavar Prescribing Information
  News & More:
The first FDA-approved blood-pool MR agent offers additional time for imaging and possibly some new applications
Thursday, 1 July 2010   by    
MRI Safety Resources 
Breast Implant - Guidance - Safety Training - Stimulator pool - Pacemaker
Blood Brain BarrierInfoSheet: - Contrast Agents - 
Intro, Overview, 
Types of, 
The brain tissue is provided with a tight endothelial layer on vessels that acts as a filter for substances that reach the brain through the blood stream. This filter is called the blood brain barrier.
The blood brain barrier is responsible for the absence of contrast agent enhancement in normal brain tissue after administration of the iodinated or paramagnetic contrast media used in brain MRI and computed tomography (CT) diagnostic. The absence of contrast uptake in normal tissue provides the basis for differentiation from pathological brain tissue, which is conversely characterized by a disruption of the blood brain barrier.
See also Contrast Enhanced MRI, MRI Safety, Adverse Reaction.
Images, Movies, Sliders:
 MRI Orbita T1  Open this link in a new window
 MRI Orbita T1 with Contrast  Open this link in a new window

• View the DATABASE results for 'Blood Brain Barrier' (7).Open this link in a new window

Further Reading:
  News & More:
Nanorobotic agents open the blood-brain barrier, offering hope for new brain treatments
Wednesday, 25 March 2015   by    
Magnetic resonance-guided motorized transcranial ultrasound system for blood-brain barrier permeabilization along arbitrary trajectories in rodents
Thursday, 24 December 2015   by    
Searchterm 'Adverse Reaction' was also found in the following services: 
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Contrast AgentsForum -
related threadsInfoSheet: - Contrast Agents - 
Intro, Overview, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
Contrast agents are chemical substances introduced to the anatomical or functional region being imaged, to increase the differences between different tissues or between normal and abnormal tissue, by altering the relaxation times. MRI contrast agents are classified by the different changes in relaxation times after their injection.
Positive contrast agents cause a reduction in the T1 relaxation time (increased signal intensity on T1 weighted images). They (appearing bright on MRI) are typically small molecular weight compounds containing as their active element Gadolinium, Manganese, or Iron. All of these elements have unpaired electron spins in their outer shells and long relaxivities.
Some typical contrast agents as gadopentetate dimeglumine, gadoteridol, and gadoterate meglumine are utilized for the central nervous system and the complete body; mangafodipir trisodium is specially used for lesions of the liver and gadodiamide for the central nervous system.
Negative contrast agents (appearing predominantly dark on MRI) are small particulate aggregates often termed superparamagnetic iron oxide (SPIO). These agents produce predominantly spin spin relaxation effects (local field inhomogeneities), which results in shorter T1 and T2 relaxation times.
SPIO's and ultrasmall superparamagnetic iron oxides (USPIO) usually consist of a crystalline iron oxide core containing thousands of iron atoms and a shell of polymer, dextran, polyethyleneglycol, and produce very high T2 relaxivities. USPIOs smaller than 300 nm cause a substantial T1 relaxation. T2 weighted effects are predominant.
A special group of negative contrast agents (appearing dark on MRI) are perfluorocarbons (perfluorochemicals), because their presence excludes the hydrogen atoms responsible for the signal in MR imaging.
The design objectives for the next generation of MR contrast agents will likely focus on prolonging intravascular retention, improving tissue targeting, and accessing new contrast mechanisms. Macromolecular paramagnetic contrast agents are being tested worldwide. Preclinical data shows that these agents demonstrate great promise for improving the quality of MR angiography, and in quantificating capillary permeability and myocardial perfusion.
Ultrasmall superparamagnetic iron oxide (USPIO) particles have been evaluated in multicenter clinical trials for lymph node MR imaging and MR angiography, with the clinical impact under discussion. In addition, a wide variety of vector and carrier molecules, including antibodies, peptides, proteins, polysaccharides, liposomes, and cells have been developed to deliver magnetic labels to specific sites. Technical advances in MR imaging will further increase the efficacy and necessity of tissue-specific MRI contrast agents.
See also Adverse Reaction and Nephrogenic Systemic Fibrosis.

See also the related poll result: 'The development of contrast agents in MRI is'
Images, Movies, Sliders:
 Delayed Myocardial Contrast Enhancement from Infarct  Open this link in a new window

Courtesy of  Robert R. Edelman
 Left Circumflex Ischemia First-pass Contrast Enhancement  Open this link in a new window
 MR Colonography Gadolinium per Rectum  Open this link in a new window

Courtesy of  Robert R. Edelman
 CE MRA of the Aorta  Open this link in a new window
SlidersSliders Overview

Radiology-tip.comContrast Agents,  Safety of Contrast Agents
Radiology-tip.comUltrasound Contrast Agents,  Ultrasound Contrast Agent Safety

• View the DATABASE results for 'Contrast Agents' (122).Open this link in a new window

• View the NEWS results for 'Contrast Agents' (25).Open this link in a new window.
Further Reading:
A safer approach for diagnostic medical imaging
Monday, 29 September 2014   by    
Contrast Agents in Magnetic Resonance Imaging
MR contrast agents: Applications in hepatobiliary imaging
Thursday, 11 November 2010   by    
  News & More:
A natural boost for MRI scans
Monday, 21 October 2013   by    
Drastic market changes with MRI contrast media and PET radiopharmaceuticals emerging as most promising segments
Thursday, 21 October 2004   by    
For MRI, time is of the essence A new generation of contrast agents could make for faster and more accurate imaging
Tuesday, 28 June 2011   by    
Searchterm 'Adverse Reaction' was also found in the following services: 
Radiology  (12) Open this link in a new windowUltrasound  (5) Open this link in a new window
Drug Development and Approval Process (USA)
Different stages of the drug development and approval process in the USA, lead from preclinical trials (testing in animals), first application in humans through limited and broad clinical tests, to postmarketing studies.

Years Test Population Purpose Success Rate
Preclinical Testing 3.5 Laboratory and animal studies Assess safety and biological activity 5,000 compounds evaluated
File IND at FDA
Phase I 1 20 to 80 healthy volunteers Determine safety and dosage 5 enter trials
Phase II 2 100 to 300 patient volunteers Evaluate effectiveness, look for side effects
Phase III 3 1000 to 3000 patient volunteers Verify effectiveness, monitor adverse reactions from long-term use
File NDA at FDA
FDA 2.5 Review process / Approval 1 approved
12 Total
Phase IV Additional Post marketing testing required by FDA

By Dale E. Wierenga, Ph.D. and C. Robert Eaton
Office of Research and Development
Pharmaceutical Manufacturers Association

'In reviewing this report, it is important to keep in mind the realities of the drug discovery and development process. The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment.'
See also Phase 1 2 3 4 Drug Trials, Food and Drug Administration, and European Medicines Agency.
Further Reading:
Guidelines for Developing Automated Quality Control Procedures for Brain Magnetic Resonance Images Acquired in Multi-Centre Clinical Trials
Tuesday, 26 April 2011   by    
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