A Multicenter, Randomized, Double-blind, Crossover, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Bayer79 sites in 5 countries402 target enrollmentStarted: June 2008Last updated: December 30, 2014

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: Bayer
Enrollment: 402
Locations: 79
Primary Endpoint: Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) 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.

Detailed Description

Issues on safety will be addressed in Adverse Events section.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Diagnostic
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Is at least 18 years of age
•Is referred for a contrast-enhanced MRI of the CNS 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, known long QT syndrome, 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

Arms & Interventions

Gadobutrol then Gadoteridol

Experimental

Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.

Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)

Gadobutrol then Gadoteridol

Experimental

Intervention: Gadoteridol (ProHance) (Drug)

Gadoteridol then Gadobutrol

Experimental

Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.

Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)

Gadoteridol then Gadobutrol

Experimental

Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.

Intervention: Gadoteridol (ProHance) (Drug)

Outcomes

Primary Outcomes

Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers