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Wednesday, July 30, 2008

Eovist Bayers new contrast for MRI

Berlin, July 8, 2008 –The U.S. Food and Drug Administration (FDA) has approved Bayer Schering Pharma’s magnetic resonance imaging (MRI) contrast agent Primovist® (gadoxetate disodium) for the detection and characterization of liver lesions in adults with known or suspected focal liver disease. The product will be marketed in the United States under the name EOVIST®; it is currently marketed as Primovist outside the U.S. and as EOB Primovist in Japan. It is the first organ-specific MRI contrast agent to be approved in the U.S. for over a decade. Bayer plans to make EOVIST available to customers in the U.S. in the summer of 2008.
“Primovist not only offers the unique benefit of being able to simultaneously detect, locate and distinguish various types of liver lesions, but also helps to guide and follow-up on treatment decisions, as it enables radiologists to identify even tiny pathological liver lesions,” said Dr. Gunnar Riemann, Member of the Board of Management of Bayer Schering Pharma AG, responsible for the company’s Business Units. “Bayer is now in the unique position of offering Primovist for diagnosing patients with liver cancer and Nexavar for treating hepatocellular carcinoma – the most common form of liver cancer.”
More info here
Contact
Doreen SchröderTelefon: +49 30 468-11399Fax: +49 30 468-16710 (berlin)
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Update Current MRI of the Liver study with Eovist.

First Received: September 28, 2010 Last Updated: October 5, 2010 History of Changes
Sponsor:Fred Hutchinson Cancer Research Center
Collaborators:Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
University of Washington
Information provided by:Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:NCT01215838
Purpose

The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions.


Condition
Hepatocellular Carcinoma

Study Type:Observational
Study Design:Observational Model: Cohort
Time Perspective: Prospective
Official Title:Dynamic Contrast Evaluation of the Liver Using Gadoxetate Disodium (Eovist®) for Hepatocellular Carcinoma (HCC)

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Accuracy of a new MR protocol in diagnosing HCC and other liver lesions. [ Time Frame: One day: participants will have one MRI of the liver. ] [ Designated as safety issue: No ]

Estimated Enrollment:200
Study Start Date:August 2010
Estimated Study Completion Date:December 2013
Estimated Primary Completion Date:December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Hepatocellular carcinoma (HCC), a form of liver cancer, is the seventh most common cause of cancer mortality in the US. The incidence rate of HCC is increasing along with the incidence of Hepatitis B and C which are known to promote HCC. Patients have a better prognosis (survival outlook) if HCC is found and treated at an early stage. MRI is the best imaging modality for diagnosing HCC.

This study will compare standard MRIs and MRIs performed with a newly developed MR protocol to determine if it is possible to more confidently diagnose HCC.



Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215838

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
University of Washington
Investigators
Principal Investigator:Orpheus Kolokythas, MDUniversity of Washington

words of wisdom



The hours of folly are measured by the clock; but of wisdom, no clock can measure. - William Blake

vasovist a new contrast for MRI

LEXINGTON, Mass.–(BUSINESS WIRE)–July 1, 2008–EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced today that the New Drug Application (NDA) for its novel blood pool magnetic resonance angiography (MRA) agent, Vasovist (gadofosveset trisodium) was resubmitted to the U.S. Food and Drug Administration (FDA) on June 30, 2008.
If approved, Vasovist will be the first contrast agent approved for marketing in the United States for use with MRA, a non-invasive modality for imaging blood vessels. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents.
We look forward to continuing to work with the FDA to bring Vasovist to market in the United States, said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. Throughout the appeal process for Vasovist, we worked closely with the FDA and the resubmission is a culmination of the work done by our team at EPIX. We remain hopeful that we will achieve approval for Vasovist by the end of 2008 and are focused on executing our strategy to monetize our interest in this valuable asset.
About Vasovist(R)
Vasovist is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA). Vasovist has been approved for marketing in 33 countries, including all 27 member states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are part of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including Germany, the Netherlands, Italy, all Nordic countries, the United Kingdom and Switzerland

Wednesday, July 23, 2008

Thank you to The Beatles for the First CAT Scan machine

As a direct result of The Beatles’ success, Dr Timmis claimed, the scanner’s inventor, Sir Godfrey Hounsfield, was able to devote about four years developing the scanner from its 1968 prototype, to something that could be used in a clinical setting. His work was done in the Central Research Laboratory, a facility near Heathrow airport that was part of the EMI Group. Having sold 200 million of the Fab Four’s singles, (at seven inches, almost enough vinyl to stretch the length of the equator) the Beatles’ record company, EMI, was able to fund Hounsfield to do his research and the CT scanner was ready be used in hospitals in the 1970’s.
Look how far we have come Aquillion 320 slice CT scanner

Check out out my friends at Mind Hacks where I first read about this story

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