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Result : Searchterm 'Clinical Trial' found in 1 term [] and 10 definitions [], (+ 2 Boolean[] results
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News  (31)  Resources  (7)  Forum  (2)  
 
MS-325Forum -
related threadsInfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
MS-325 is the formerly code name of gadofosveset trisodium (new trade name Vasovist). MS-325 belongs to a new class of blood pool agents for magnetic resonance angiography (MRA) to diagnose vascular disease. Gadofosveset trisodium has ten times the signal-enhancing power of existing contrast agents as well as prolonged retention in the blood. This enables the rapid acquisition of high resolution MRA's using standard MRI machines.
Gadofosveset trisodium, which is gadolinium-based, stays in the blood stream as a result of transient binding to albumin. Albumin binding offers an additional benefit beyond localization in the blood pool. The contrast agent begins to spin much more slowly, at the rate albumin spins, causing a relaxivity gain that produces a substantially brighter signal than would be possible with freely circulating gadolinium. MS-325 is an intravascular contrast agent intended for use in MRI as an aid in diagnosing aortoiliac occlusive disease in patients with known or suspected peripheral vascular disease (PVD) or abdominal aortic aneurysm (AAA).
Currently clinical trials completed for peripheral vascular disease and coronary artery disease. Additional trials are also being conducted to evaluate MS-325 as an aid in diagnosing breast cancer and suggested that it might be feasible to combine the use of MS-325, injected during peak stress, with delayed high-resolution imaging to identify myocardial perfusion defects.
Vasovist (MS-325) would compete with the contrast agents Ferumoxytol (Code 7228) from AMAG Pharmaceuticals, Inc. and NC100150 Injection from Nycomed Amersham, but their further development is uncertain.
Partners in development: EPIX Pharmaceuticals, Inc., Mallinckrodt Inc., and Bayer Schering Pharma AG. Bayer Schering Pharma has the worldwide marketing rights for the product.
Formerly known under the Mallinckrodt trademark name, AngioMARKĀ®.

See also Classifications, Characteristics, etc.
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• View the NEWS results for 'MS-325' (10).Open this link in a new window.
 
Further Reading:
  News & More:
EPIX Medical's new multimedia Web site features AngioMARK images in 3D
Friday, 5 March 1999
MRI technology combined with contrast agent optimizes diagnosis of cardiovascular disease
1999
Searchterm 'Clinical Trial' was also found in the following services: 
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Radiology  (3) Open this link in a new windowUltrasound  (5) Open this link in a new window
P792InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
Short name: P792, generic name: Gadomeritol, preliminary trade name: Vistaremā„¢, central moiety: Gd
A macromolecular Gd-DOTA derivate under development as a MRI blood pool agent with rapid clearance. Phase II of the clinical trials on P792 (Guerbet SA) will make it possible to validate the performance of this agent in the fields of angiography, myocardial perfusion and tumor characterization.
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• View the DATABASE results for 'P792' (2).Open this link in a new window


• View the NEWS results for 'P792' (1).Open this link in a new window.
 
Further Reading:
  News & More:
The Toolbox Indirectly, tissue is the issue
MRI Resources 
Pacemaker - Societies - Open Directory Project - Anatomy - Resources - Software
 
Phase 1, 2, 3, 4 Drug Trials
 
Different stages of testing drugs in humans, from first application in humans through limited and broad clinical tests, to postmarketing studies. Preclinical trials are the testing in animals.
Phase I: Safety, pharmacokinetics
Phase II: Dose
Phase III: Efficacy
Phase IV: Postmarketing
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Searchterm 'Clinical Trial' was also found in the following services: 
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News  (31)  Resources  (7)  Forum  (2)  
 
ResovistĀ®InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
ResovistĀ® is an organ-specific MRI contrast agent, used for the detection and characterization of especially small focal liver lesions.
ResovistĀ® consists of superparamagnetic iron oxide (SPIO) nanoparticles coated with carboxydextran, which are accumulated by phagocytosis in cells of the reticuloendothelial system (RES) of the liver. The uptake of ResovistĀ® Injection in the reticuloendothelial cells results in a decrease of the signal intensity of normal liver parenchyma on both T2- and T1 weighted images.
Most malignant liver tumors do not contain RES cells and therefore do not uptake the iron particles. The resulting imaging effect is an improved contrast between the tumor (bright) and the surrounding tissue (dark).
ResovistĀ® can be injected as an intravenous bolus, which allows immediate imaging of the liver and reduces the overall examination time. A dynamic imaging strategy after bolus injection supports to characterize lesions. In comprehensive clinical trials, it demonstrated an excellent safety profile.
In 2001, ResovistĀ® was approved for the European market.

See also Superparamagnetic Iron Oxide.

ResovistĀ® competed with Primovistā„¢, the other liver imaging agent of Bayer Schering Pharma AG. Due to this reason, the production of ResovistĀ® has been abandoned in 2009.
Drug Information and Specification
NAME OF COMPOUND
Ferrixan [Ferucarbotran], carboxydextran coated iron oxide nanoparticles
CENTRAL MOIETY
Fe2+
CONTRAST EFFECT
T2/T1, Predominantly negative enhancement
r1=25.4, r2=151,
PHARMACOKINETIC
RES-directed
333 mosm/kg
CONCENTRATION
0.5 mol Fe/L
DOSAGE
Less than 60 kg = 0.9 ml, greater than 60 kg = 1.4 ml
PREPARATION
Finished product
INDICATION
Liver lesions
DISTRIBUTOR
See below
PRESENTATION
Pre-filled syringes of 0.9 and 1.4 mL
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE
NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT!
Distribution Information
TERRITORY
TRADE NAME
DEVELOPMENT
STAGE
DISTRIBUTOR
USA
ResovistĀ®
?
-
Japan
ResovistĀ®
approved
-
EU
ResovistĀ®
approved
-
Australia
ResovistĀ®
Approved
-
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• View the DATABASE results for 'Resovist®' (6).Open this link in a new window

 
Further Reading:
  News & More:
Optimized Labelling of Human Monocytes with Iron Oxide MR Contrast Agents
Sunday, 30 November 2003   by rsna2003.rsna.org    
Searchterm 'Clinical Trial' was also found in the following services: 
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Radiology  (3) Open this link in a new windowUltrasound  (5) Open this link in a new window
TeslascanĀ®InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
(Mn-DPDP) This agent, mangafodipir trisodium, is a hepatocyte specific MRI contrast agent. Manganese is very toxic, so it has to be chelated and put in the form of a vitamin B6 analog, which is taken up by normal hepatocytes to some extent.
TeslascanĀ® was developed in the early 1980's, went through clinical trials in the early 1990's, and was approved in 1997. One problem with assessing the efficacy of this agent is the fact that the phase III trials finished in the early 1990's, and the techniques used for MR today are very different from the techniques used almost a decade ago.
This contrast agent shortens the T1 relaxation time. On T1 weighted pictures it makes a normal liver look brighter. Since metastases, for example, do not generally take up this agent, the contrast between the enhancing liver and the non-enhancing lesions will increase on T1 weighted pictures. It does not have much effect on T2 weighted images.
Drug Information and Specification
NAME OF COMPOUND
Mangafodipir trisodium, Manganese dipyroxyl diphosphate, MN-DPDP
DEVELOPER
CENTRAL MOIETY
Mn2+
CONTRAST EFFECT
T1, Predominantly positive enhancement
r1=2.3, r2=4.0, B0=1.0 T
PHARMACOKINETIC
Hepatobiliary, pancreatic, adrenal
290 mosm/kgH2O
CONCENTRATION
0.01 mmol/L
DOSAGE
5 ƂĀµmol/kg, 0.5 ml/kg
PREPARATION
Finished product
INDICATION
Liver lesions
DEVELOPMENT STAGE
Approved
DISTRIBUTOR
See below
PRESENTATION
Vials of 100 ml
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE
NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT!
Distribution Information
TERRITORY
TRADE NAME
DEVELOPMENT
STAGE
DISTRIBUTOR
USA
TeslascanĀ®
for sale
EU
TeslascanĀ®
for sale
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• View the DATABASE results for 'Teslascan®' (4).Open this link in a new window

 
Further Reading:
  Basics:
EMEA - Teslascan - SCIENTIFIC DISCUSSION(.pdf)
   by www.emea.europa.eu    
  News & More:
Diagnosis and staging of pancreatic cancer: comparison of mangafodipir trisodium-enhanced MR imaging and contrast-enhanced helical hydro-CT.
2002
MAGNETIC RESONANCE IMAGING OF FOCAL LIVER LESIONS(.pdf)
2002
MRI Resources 
Most Wanted - Universities - Service and Support - Absorption and Emission - Guidance - Resources
 
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