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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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 in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet
• Treatments: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Criteria

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.