Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Condition: Brain Diseases; Spinal Cord Diseases
MeSH terms: Brain Diseases; Spinal Cord Diseases
Intervention: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875); Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875); Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875); OptiMARK~0.1 mmol/kg BW
Intervention description: Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.; Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.; Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.; Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Contrast Agents

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 Gadavist when used for taking images of the brain and spine. The
      results of the MRI with Gadavist Injection will be compared to the results of MR images taken
      without contrast and with the results of the MR images taken with OptiMARK.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with either known or highly suspected focal areas of disruption of the blood
             brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or
             demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to
             undergo a routine contrast-enhanced MRI of the CNS.

          -  Patients with untreated brain tumors should constitute a minimum of 50% of the study
             population and patients with treated brain tumors will be limited to a maximum of 20%
             of the study population

        Exclusion Criteria:

          -  Is a female patient who is pregnant or nursing.

          -  Is a female of childbearing potential and did not have a negative urine pregnancy test
             the same day as the administration of gadobutrol or comparator treatment.

          -  Has received any investigational product within 30 days prior to enrolling in this
             study.

          -  Has been previously enrolled in this study or any other study using gadobutrol.

          -  Has any contraindication to the MRI examinations.

          -  Has a history of severe allergic or anaphylactoid reaction to any allergen including
             drugs and contrast agents.

          -  Has received any contrast agent within 24 hours prior to gadobutrol contrast
             administration, or is scheduled to receive any contrast agent within 72 hours after
             the gadobutrol study.

          -  Is considered to be clinically unstable or his/her clinical course during the study
             period is unpredictable (eg, due to previous surgery, acute renal failure).

          -  Has been treated with high dose (>55 cobalt Gy equivalent) photon radiation or global
             radiotherapy for CNS lesions at any time before entering the study.

          -  Is scheduled to receive chemotherapy or radiotherapy during the study period.

          -  Is expected or scheduled to have a change in any treatment or procedure between the
             comparator and gadobutrol MRIs that may alter their interpretation.

          -  Is scheduled or is likely to require a biopsy or surgery within the 72 hours after the
             gadobutrol MRI procedure, or is scheduled for or has undergone such interventions
             between the comparator and gadobutrol studies.

          -  Has severe cardiovascular disease.

          -  Has any contraindication to OptiMARK according to the package insert.

          -  Has more than 30 brain lesions detected by any prior imaging examination.