Crossover Comparison of MultiHance and Dotarem
Condition: Brain Disease
MeSH terms: Brain Diseases
Intervention: MultiHance 0.1 mmol/kg; Dotarem; MultiHance 0.05 mmol/kg
Intervention description: MultiHance administered at 0.1 mmol/kg; Dotarem administered at 0.1 mmol/kg; MultiHance administered at 0.05 mmol/kg
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: confirmed brain disease; highly suspected brain disease

Summary:

      This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg
      and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of
      MultiHance.
    

Eligibility criteria:

        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 brain surgery and are to be evaluated for recurrence

        Exclusion Criteria:

          -  Are pregnant or lactating females. Exclude the possibility of pregnancy:

          -  By testing on site at the institution within 24 hours prior to the start of each
             investigational product administration; or

          -  By history (i.e., tubal ligation or hysterectomy); or

          -  Post menopausal with a minimum of 1 year without menses

          -  Have any known allergy to one or more of the ingredients in the investigational
             products, 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 hours
             preceding through the 24 hours following Exam 1, and in the 24 hours preceding through
             the 24 hours 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 hours
             post-administration of the second investigational product

          -  Have moderate-to-severe renal impairment, defined as Glomerular Filtration Rate
             (GFR)/estimated GFR < 45 mL/min

          -  Have been previously entered into this study

          -  Have received or are scheduled for one of the following:

          -  Surgical or chemotherapeutic treatment 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