Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain

Phase IV, Double-Blind, Multi-Center, Randomized, Crossover Study to Compare 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® in Magnetic Resonance Imaging (MRI) of the Brain

This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.

Inclusion Criteria:

• Enroll subjects in this study if they meet the following inclusion criteria:
• Are at least 18 years of age or older
• Are able to give written informed consent and are willing to comply with the protocol requirements
• Are scheduled to undergo MRI
• Are willing to undergo two MRI procedures within 14 days
• Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
• clinical/neurological symptomatology;
• diagnostic testing, such as CT or previous MRI examinations; or
• have had recent surgery within 6 months and are to be evaluated for recurrence.

Exclusion Criteria:

• Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed.
• Are pregnant or lactating females. Exclude the possibility of pregnancy:
• by testing on site at the institution (serum or urine bHCG) within 24 h prior to the start of each investigational product administration
• by history (i.e., tubal ligation or hysterectomy)
• post menopausal with a minimum of 1 year without menses
• Have any known allergy to one or more of the ingredients in the investigational product, or have a history of hypersensitivity to any metals
• Have congestive heart failure (class IV according to the classification of the New York Heart Association
• Have suffered a stroke within a year
• Have received or are scheduled to receive any other contrast medium in the 24 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h following Exam 2
• Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 h post-administration of the second investigational product.
• Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 mL/min.
• Have been previously entered into this study
• Have received or are scheduled for one of the following:
• Surgery within three weeks prior to the first examination or between the two examinations
• Initiation of steroid therapy between the two examinations
• Radiosurgery between the two examinations
• Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field.
• Are suffering from severe claustrophobia
• Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations