Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain
Condition: Brain Disease
MeSH terms: Brain Diseases
Intervention: gadoteridol; gadobutrol
Intervention description: ProHance 0.1 mmol/kg; Gadovist/Gadavist 0.1 mmol/kg
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Have confirmed or are highly suspected of brain disease

Summary:

      This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated
      comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects
      with brain tumors to confirm the identical overall technical and diagnostic performance of
      the two MR contrast agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are scheduled to undergo MRI

          -  Are willing to undergo two MRI procedures within 14 days

          -  Have confirmed or are highly suspected of brain disease likely to enhance as
             determined by the following:

          -  Clinical/neurological symptomatology;

          -  Diagnostic testing, such as CT or previous MRI examinations; or

          -  Have had previous 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; see Appendix A)

          -  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 a GFR/eGFR < 45 mL/min.

          -  Have been previously entered into this study

          -  Have received or are scheduled for one of the following:

          -  Surgery 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