You have been diagnosed or suspected by your doctor to have a focal liver lesion that needs further evaluation in order to make an accurate diagnosis. You will need to have an enhanced magnetic resonance imaging (MRI) scan so that your doctor can have further information about the number and characteristics of the focal liver lesion(s).

You and 190 other patients will be invited to take part in this clinical study. The purpose of this study is to evaluate Primovist, which is a liver-specific MRI contrast medium, on the efficacy of lesion detection and characterization, and tolerability in Chinese patients with known or suspected focal liver lesions.

Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium developed by Bayer Schering Pharma AG. Its active substance is Gd-EOB-DTPA. Primovist was first approved in 2004 in Sweden followed by an approval in the European community, in Switzerland and Australia in the same year.

Procedures:

Before entry into the study and after entry of the study a physical examination will be conducted, blood pressure and heart rate will be measured, blood and urine samples will be taken. Current medications and medical conditions (including suspected pregnancy) and medical and surgical history will be elicited by your doctor. .

After entry into the study, you will be scheduled to have an MRI examination, which lasts about 25-35 minutes.

During the MRI examination, an initial MRI scan without contrast will be acquired. This will be followed by another MRI series after the intravenous administration of Primovist.

The following day you will be asked to return to the hospital for a follow-up safety evaluation.

Possible Benefit You are scheduled to receive an enhanced magnetic resonance imaging scan. Clinical studies indicate that Primovist increases the efficacy of detection and characterization of focal liver lesions by providing better contrast between the focal liver lesions and surrounding normal tissue. Primovist were shown to provide additional information regarding existence, number and characterization (lesion or non-lesion, malignant or benign) of these abnormalities.

Based on the experience with patients given Primovist, some adverse reactions were observed.

Most of undesirable effects were transient and of mild to moderate intensity. The most commonly noted AEs in subjects receiving Primovist for MRI were nausea and headache with an incidence of 1.1%. Other AEs that occurred in 0.5% of the subject population were feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%).

All other AEs occurred in less than 0.5% of the patients, e.g. anxiety; coughing; eye disorder; fever; flatulence; generalized spasm; hypertension; injection site symptoms including edema, inflammation, and reaction; lightheadedness; parosmia; postural hypotension; taste perversion, motoric unrest; acute respiratory distress; fatigue; malaise; vomiting; palpitations, erythema, chest pain and back pain.

Coldness, warmth or pain at the injection site, injection site reaction, and injection site accumulation of fluid were rare. In very rare cases strong allergy-like reactions ranging to shock may occur.

Post-marketing tachycardia and restlessness have been reported. As in the case of other investigational drugs, there may also be unforeseen side effects.

Additional information concerning all Gadolinium- based contrast agents Primovist contains the rare earth metal gadolinium as active ingredient. There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents (especially Omniscan) in patients with severe renal impairment. NSF is a systemic disease characterised by formation of connective tissue in the skin, which becomes thickened and hard, sometimes leading to contractures and joint immobility. The clinical course is usually progressive and currently no treatment is available. To date NSF has only been reported in association with some Gd-containing contrast agents, but the role of these contrast agents in the overall pathogenesis of the disease is still not completely understood.

No reports of patients with NSF after administration of Primovist® are known. The risk to trigger NSF in risk patients with severe renal impairment is considered to be low for Primovist® due to the low dose given and the additional excretion via feces. Furthermore the participation of patients with severe renal impairment are excluded from this study.

In case you are suffering from renal insufficiency, please tell your doctor prior to application of the contrast agent. In case you experience any new alterations of the skin following the administration of the contrast agent, please contact your doctor as soon as possible after you have recognized these symptoms.