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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000455369

Enrollment

402

Registered

2008-09-15

Start date

2008-06-11

Completion date

2009-03-23

Last updated

2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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®.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Diagnosis

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results