Study to Assess Efficacy and Safety of Contrast Agents in MR Mammography

The trial will evaluate the efficacy and safety of Gadovist in contrast-enhanced breast MR mammography (MRM).

Gadovist is already approved for the most frequently used contrast-enhanced MRI examinations including imaging of the central nervous system, the liver, kidney, and for imaging of blood vessels in adults and for the use in children aged two years and older.

"As a pioneer in contrast-media research, Bayer is continuously working to provide physicians with high-quality contrast media for use in various indications of contrast enhanced MRI,” said Thomas Balzer, head of global clinical development diagnostic imaging at Bayer Schering Pharma, AG (Berlin, Germany). "Due to its high T1-shortening--an important characteristic in the field of radiology--Gadovist offers a potentially excellent image quality in MRI and thus could be very valuable in MRM.”

The objective of this multicenter, open-label, nonrandomized phase III study with corresponding blinded image evaluations is to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of Gadobutrol 1.0 Molar (Gadovist) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI. The extent of malignant disease will be determined and compared between various imaging approaches, including unenhanced breast MRI, gadobutrol-enhanced MRI, and X-ray mammography. The active enrollment phase III will cover one year with the estimated completion date around beginning 2011.

With about 1.3 million new cases every year, breast cancer is the most common form of cancer among women today. Diagnostic imaging plays an important role in the detection and management of this devastating disease. MRI is considered the most sensitive method for detection of breast cancer and the best method to exclude additional cancer lesions. Therefore, it is used as an adjunct to X-ray mammography for, e.g., screening high-risk patients, preoperative tumor staging, tracking response to neo-adjuvant chemotherapy, and evaluating breast implants. The MRI procedure consists of unenhanced and contrast-enhanced MRI scans to differentiate into benign and malignant lesions using morphologic (shape and margin) and dynamic (contrast enhancement, signal intensity time curves) criteria. The performance of MRI strongly depends on the efficacy and safety of the applied contrast agent.

Gadovist is a highly efficient contrast agent, approved for the contrast-enhanced MRI of various parts of the body, including the brain, spinal cord, liver, kidney, and the blood-vessel system. With its 1.0 mol/L concentration of gadobutrol, a stable macrocyclic gadolinium compound, Gadovist contains twice as much gadolinium per unit of volume as other extracellular contrast media available on the market. Moreover, Gadovist has a high T1-relaxivity in plasma. Due to its combination of high concentration and high relaxivity, Gadovist exhibits the highest T1-shortening per mL of all gadolinium contrast media. This results in potentially excellent image quality and offers practical advantages in the case of smaller injection volumes. Gadovist received market authorization for the first time in 1998 and it is now approved in over 50 countries.

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition, and high-tech materials. Bayer HealthCare (Leverkusen, Germany), a subsidiary of Bayer AG, is one of the world's leading innovative companies in the healthcare and medical products industry. The company combines the global activities of the animal health, Bayer Schering Pharma, consumer care and medical care divisions. Bayer HealthCare's goal is to discover, manufacture, and market products that will improve human and animal health worldwide.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: diagnostic imaging, general Medicine, specialty medicine, and women's healthcare.

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