A multicenter, randomized, double-blind, crossover, phase 3 study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist®) in patients referred for contrast-enhanced MRI of the central nervous system (CNS)

• Conditions: Male and female patients of any ethnic group who are referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure.; MedDRA version: 9.1Level: LLTClassification code 10061816Term: Diagnostic procedure

• Registration Number: EUCTR2007-004746-33-DE
• Lead Sponsor: Bayer HealthCare Pharmaceuticals INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-21
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

A patient who meets the following criteria will be eligible for enrollment into the study:
1.Is at least 18 years of age
2.Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure
3.Is willing to undergo the routine contrast-enhanced MRI examinations with gadoteridol and with gadobutrol
4.Is willing and able to complete all study procedures specified in the protocol
5.Patient is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test within 1 hour prior to the administration of gadobutrol and gadoteridol
6.Has a glomerular filtration rate (GFR) value = 60 mL/min/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment
7.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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient who meets any of the following criteria may not participate in this study:
1.Is a female patient who is pregnant or nursing
2.Has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study
3.Has been previously enrolled in this study or any other study using gadobutrol
4.Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
5.Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
6.Has received any contrast agent within 24 hours prior to the study MRIs, or is scheduled to receive any contrast agent within 72 hours after the second study MRI
7.Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure)
8.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)
9.Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
10.Has any contraindication to gadoteridol according to the package insert
11.Is expected or is scheduled to have a change in any treatment or procedure between the gadoteridol and gadobutrol MRIs that may alter their interpretation
12.Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 72 hours after the second study MRI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified