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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

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