Results from the Largest Ever CNS MR Crossover Investigation Published Online by RSNA Journal Radiology.

PRINCETON, N.J. -- Results from a large multicenter, randomized, double blind crossover, intraindividual comparison of two contrast agents for magnetic resonance imaging (MRI) have been published online by Radiology. In the study titled "Contrast Enhancement of Central Nervous System Lesions: Multicenter Intraindividual Crossover Comparative Study of Two MR Contrast Agents" the authors conclude: "The findings in our study indicate that MultiHance(R)(gadobenate dimeglumine) injection, 529 mg/mL provides significantly improved conspicuity of CNS lesions and greater lesion-to-brain enhancement than does Magnevist(R) (gadopentetate dimeglumine) injection, at the same dose."

One of the study's principal investigators, Ken Maravilla, MD, of the University of Washington in Seattle, Washington, said the study produced "significant findings relative to the performance of one of the most widely used gadolinium agents administered in MRI procedures to improve the conspicuity and detectability of central nervous system (CNS) lesions."

Also known as the "MH-109" clinical trial, the study compared equivalent doses (0.1 mmol/kg, 0.2 mL/kg) of MultiHance and Magnevist in 157 patients referred for contrast-enhanced MR examinations of the brain or spine. Each patient received both agents and acted as his/her own control.

"The key importance of this study is that it was the largest clinical investigation of this kind ever to focus on contrast agents used for MRI," said Maravilla. "And, it showed some clear advantages relative to performance associated with using the higher relaxivity agent versus another well known widely used gadolinium agent. I think readers of Radiology will find the details in the publication to be compelling."

Statistically significant (p less than 0.0001; all readers, all comparisons) results for MultiHance were demonstrated for each individual diagnostic information endpoint used in the study, as well as quantitative parameters linked to the contrast enhancement obtained with the two agents (percent of enhancement of signal intensity in the CNS lesions, contrast-to-noise ratio, CNR). The authors noted that the greater contrast enhancement achieved with MultiHance corresponds with that which would be expected by doubling the dose of Magnevist, as might be expected on the basis of the roughly twofold greater T1 relaxivity of MultiHance in blood.

The design and conduct of study MH-109 were very rigorous and well suited to compare the performance of the two agents. The two contrast injections were performed in a blinded and fully randomized manner with an interval of 2-7 days between administrations, to avoid any carryover effects. Half of the patients received MultiHance for their first exam and the remaining half received Magnevist first. Imaging parameters and post-dose acquisition times were kept identical for the two exams in each patient. Images were evaluated by three independent and experienced neuroradiologists, who were unaffiliated with the enrollment centers and fully blinded to any clinical information about the patients and the agents used in the two exams. Image assessments were made in terms of diagnostic information (lesion border delineation, definition of disease extent, visualization of lesion internal morphology, lesion contrast enhancement) and quantitative parameters (percent of enhancement and CNR).

Bracco received FDA approval to market MultiHance in the USA in November 2004. MultiHance is indicated for intravenous use in MRI of the central nervous system in adults to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.

MultiHance has features that distinguish it from other contrast agents. As reported in the FDA-approved package insert, MultiHance, unlike other available gadolinium contrast agents, demonstrates weak and transient interactions with serum proteins, which result in a proton magnetic relaxivity that is approximately twice that of Magnevist. The higher relaxivity of MultiHance may result in greater signal intensity enhancement and better contrast enhancement at equivalent dose.

"Bracco Diagnostics believes that MultiHance offers significant clinical and operational advantages in the MRI arena, and we are pleased that this large-scale, clinical investigation took place," noted Carlo Medici, president and chief executive officer of Bracco Diagnostics Inc.

About MultiHance

As with all paramagnetic agents, caution should be exercised in patients with deoxygenated sickle erythrocytes.

The possibility of a reaction, including serious, life-threatening, or fatal, anaphylactic or cardiovascular reactions, or other idiosyncratic reactions, should always be considered, especially in those patients with a history of known clinical hypersensitivity or a history of asthma or allergic respiratory disorders.

About Bracco

The Bracco Group is a world-leading provider of global diagnostic imaging solutions, with net sales of about 800 million Euros per year. Bracco has operations in 115 countries and about 2,200 employees, around 400 of whom work in R & D. Bracco invests approximately 15% of its annual turnover in R & D and has a portfolio of 1,500 patents worldwide.

The Bracco Group is a leader in the diagnostic imaging market with an integrated product offering from a diverse roster of subsidiary companies. While Bracco is recognized internationally as a definitive market leader in its core business of contrast media, Bracco also markets key diagnostic imaging resources through the following companies: ACIST Medical Systems, a manufacturer of advanced contrast media injection systems and Singapore-based Volume Interactions, which also produces advanced 3-D medical software.

Bracco also operates a high-level international research network, with three centers (Milan, Geneva, and Princeton). These centers develop products of the latest-generation diagnostic techniques, from X-ray and computed tomography (CT) to magnetic resonance imaging (MRI), echocontrast and nuclear medicine.

For further information, please visit www.multihanceUSA.com.

Magnevist is a registered copyright of Berlex Imaging.

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