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

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called
Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and
efficacy (how well does it work) of Dotarem® when used for taking images of the brain and
spine. The results of the MRI will be compared to the results of images taken without
Dotarem®.

Inclusion Criteria:

- Adult subject and pediatric subjects (aged greater than or equal to two (2) years).

- Is referred for a contrast-enhanced MRI of the CNS based on the results of a previous
imaging procedure.

- Female of childbearing potential patients must have effective contraception
(contraceptive pill or intra-uterine device) or be surgically sterilized or
post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine
pregnancy test within 24 hours prior to study MRI.

- Has been fully informed about the study, and has consented to participate.

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.