Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

Exclusion Criteria

• •Having acute or chronic grade IV or V renal insufficiency.
• •Known class III/IV congestive heart failure.
• •Suffering from long QT syndrome.
• •Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).
• •Having any contraindications to MRI such as a pace-maker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field.
• •Known allergy to Gadolinium chelates.
• •Having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration.
• •Pregnant, breast feeding, or planning to become pregnant during the trial.
• •Previously participated in this trial.
• •Having participated within 30 days in another clinical trial involving an investigational drug.
• •Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.
• •Inability or unwillingness to cooperate with the requirements of this trial.