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Result : Searchterm 'Clinical Trial' found in 1 term [] and 10 definitions [], (+ 2 Boolean[] results
| previous 11 - 13 (of 13) Result Pages : [1] [2 3] | | | | Searchterm 'Clinical Trial' was also found in the following services: | | | | |
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Vasovist™ is an albumin-targeted intravascular contrast agent. It is indicated for contrast enhanced MR angiography (CE-MRA) for the visualization of abdominal or limb vessels in patients with suspected or known vascular disease. After IV injection, Vasovist™ binds reversibly to human albumin in plasma, which results in long-lasting increased relaxivity. Imaging from 5 to 50 min is possible. A small unbound portion is, by glomerular filtration, eliminated by the kidneys.
AngioMARK® was the formerly trade name and MS-325 the research name. Currently the phase III clinical trials are completed to determine its efficacy for peripheral vascular disease and coronary artery disease.
In the U.S., EPIX received an approvable letter from the U.S. Food and Drug Administration (FDA) for Vasovist™ in January 2005. In 2009, Epix Pharmaceuticals has sold the U.S., Canadian and Australian rights for its blood pool agent (now named ABLAVAR™), to Lantheus Medical Imaging, Inc..
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/1.73m 2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or the liver transplantation period.
See also MRI Safety.
Drug Information and Specification NAME OF COMPOUND Diphenylcyclohexyl phosphodiester-Gd-DTPA, gadofosveset trisodium, MS-325 T1, predominantly positive enhancement 20-45 mmol-1sec-1, Bo=0,47T PHARMACOKINETIC Intravascular, short elimination half life CONCENTRATION 244 mg/mL, 0.25mmol/mL DOSAGE 0.12 mL/kg, 0.03 mmol/kg DEVELOPMENT STAGE approved 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 North America, Australia for sale | | | | | Further Reading: | Basics:
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[This entry is marked for removal.]
(July 20, 2009 - EPIX Pharmaceuticals, Inc. announced today that, in light of the company's lack of capital and inability to obtain additional financing or consummate a strategic transaction, it has entered into an Assignment for the Benefit of Creditors, effective immediately, in accordance with Massachusetts law).
EPIX has been a specialty pharmaceutical firm developing targeted contrast agents to improve the capability of MRI as a diagnostic tool for a variety of diseases. Gadofosveset trisodium (formerly MS-325, Vasovist™, now ABLAVARt™), is an injectable intravascular contrast agents designed for multiple vascular imaging applications, including peripheral vascular disease and coronary artery disease.
EPIX conducted a pivotal Phase III trial for the detection of peripheral vascular disease, as well as a Phase II feasibility trial for coronary artery disease diagnosis.
To ensure rapid development and adoption of gadofosveset trisodium into clinical practice upon regulatory approval, EPIX pursued an aggressive product development plan and commercialization strategy. The Company established an exclusive, worldwide sales and marketing agreement with Bayer Schering Pharma AG. EPIX also established corporate collaborations with GE Healthcare, Philips Medical Systems and Siemens Medical Systems, the three leading MRI manufacturers, which together account for approximately 80 percent of the MRI machines installed worldwide.
EPIX had other MRI contrast agents under development, most significantly a novel prototype blood clot agent ( EP-2104R). Potential clinical applications for this type of agent include detection of deep venous thrombosis, pulmonary embolism and blood clots in the coronary and carotid arteries. Currently, there is no high resolution imaging technique to directly visualize blood clots in patients with suspected cardiovascular disease.
| | | | • View the DATABASE results for 'EPIX Pharmaceuticals, Inc.' (7).
| | | • View the NEWS results for 'EPIX Pharmaceuticals, Inc.' (69).
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The subacute risks and side effects of magnetic and RF fields (for patients and staff) have been intensively examined for a long time, but there have been no long-term studies following persons who have been exposed to the static magnetic fields used in MRI. However, no permanent hazardous effects of a static magnetic field exposure upon human beings have yet been demonstrated.
Temporary possible side effects of high magnetic and RF fields:
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Varying magnetic fields can induce so-called magnetic phosphenes that occur when an individual is subject to rapid changes of 2-5 T/s, which can produce a flashing sensation in the eyes. This temporary side effect does not seem to damage the eyes. Static field strengths used for clinical MRI examinations vary between 0.2 and 3.0 tesla;; field changes during the MRI scan vary in the dimension of mT/s. Experimental imaging units can use higher field strengths of up to 14.0 T, which are not approved for human use.
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The Radio frequency pulses mainly produce heat, which is absorbed by the body tissue. If the power of the RF radiation is very high, the patient may be heated too much. To avoid this heating, the limit of RF exposure in MRI is up to the maximum specific absorption rate (SAR) of 4 W/kg whole body weight (can be different from country to country). For MRI safety reasons, the MRI machine starts no sequence, if the SAR limit is exceeded.
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Very high static magnetic fields are needed to reduce the conductivity of nerves perceptibly. Augmentation of T waves is observed at fields used in standard imaging but this side effect in MRI is completely reversible upon removal from the magnet. Cardiac arrhythmia threshold is typically set to 7-10 tesla. The magnetohydrodynamic effect, which results from a voltage occurring across a vessel in a magnetic field and percolated by a saline solution such as blood, is irrelevant at the field strengths used.
The results of some animal and cellular studies suggest the possibility that electromagnetic fields may act as co-carcinogens or tumor promoters, but the data are inconclusive.
Up to 45 tesla, no important effects on enzyme systems have been observed. Neither changes in enzyme kinetics, nor orientation changes in macromolecules have been conclusively demonstrated.
There are some publications associating an increase in the incidence of leukemia with the location of buildings close to high-current power lines with extremely low-frequency (ELF) electromagnetic radiation of 50-60 Hz, and indus trial exposure to electric and magnetic fields but a transposition of such effects to MRI or MRS seems unlikely.
Under consideration of the MRI safety guidelines, real dangers or risks of an exposure with common MRI field strengths up to 3 tesla as well as the RF exposure during the MRI scan, are not to be expected.
For more MRI safety information see also Nerve Conductivity,
Contraindications, Pregnancy
and Specific Absorption Rate.
See also the related poll result: ' In 2010 your scanner will probably work with a field strength of' | | | | • View the DATABASE results for 'MRI Risks' (9).
| | | • View the NEWS results for 'MRI Risks' (3).
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