Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
Condition: Diagnostic Self Evaluation; Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases
Intervention: Dotarem (gadoterate meglumine); Magnevist (gadopentetate dimeglumine)
Intervention description: 0.1 mmol/kg by body weight, single IV injection; 0.1 mmol/kg by body weight, single IV injection
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 416.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: CNS; Contrast Agent; MRI; Dotarem; Magnevist

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.
    

Eligibility 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.