Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

Bayer

Status and phase: Completed; Phase 3

Conditions: Central Nervous System Diseases; Diagnostic Imaging

Treatments: Drug: Gadoteridol (ProHance); Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709852

310123 (Other Identifier)

91681

2007-004746-33 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Issues on safety will be addressed in Adverse Events section.

Enrollment: 402 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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402 participants in 2 patient groups

Gadobutrol then Gadoteridol

Experimental group

Description:

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.

Treatment:

Drug: Gadoteridol (ProHance)

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

Gadoteridol then Gadobutrol

Experimental group

Description:

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.

Treatment:

Drug: Gadoteridol (ProHance)

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