A clinical study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist 'Registered trade mark') in comparison to ProHance 'Registered trade mark' (gadoteridol) 0.5 molar in patients referred for contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system.
A multicenter, randomized, double-blind, crossover, phase 3 study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist 'Registered trade mark') in patients referred for contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system (CNS). Protocol number 310123
Bayer Australia Ltd
402 participants
Jun 11, 2008
Interventional
Conditions
Summary
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadovist®) Injection and ProHance® Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance®.
Eligibility
Inclusion Criteria2
- Is referred for a contrast-enhanced MRI of the Central Nervous System based on current clinical symptoms or results of a previous imaging procedure.
- Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate.
Exclusion Criteria4
- Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents.
- Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.
- Has severe cardiovascular disease (eg, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours).
- Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period.
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Interventions
Drug: Gadovist 'Registered trade mark' (Gadobutrol) 1.0 molar; dose 0.1 mmol/kg; route of administration intravenous; duration of treatment is single dose;washout period 24 hours; MRI using steady state sequences.
Locations(7)
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ACTRN12608000455369