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

Condition(s) targeted: Diagnostic Imaging; Central Nervous System Diseases

Intervention: Gadovist (Gadobutrol) (Drug); ProHance (Gadoteridol) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Official title: 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)

Study design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome:

To demonstrate superiority of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI).

To demonstrate noninferiority of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI).

Secondary outcome:

To demonstrate noninferiority of gadobutrol compared to gadoteridol for: degree of contrast enhancement, border delineation, internal morphology, total number of lesions

Demonstrate improvement of gadobutrol-enhanced MRI to unenhanced MRI and noninferiority to gadoteridol-enhanced MRI for: exact match of the MR diagnoses with the final clinical diagnosis

Assess the safety profile of gadobutrol compared to gadoteridol after intravenous (IV) administration

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Wien 1090, Austria; Recruiting

Cali, Colombia; Not yet recruiting

Bogotá, Colombia; Not yet recruiting

Berlin 10117, Germany; Not yet recruiting

Lucknow 226 014, India; Not yet recruiting

Mumbai 400020, India; Not yet recruiting

Kyoto 616-8255, Japan; Recruiting

Osaka 540-0006, Japan; Recruiting

Osaka 537-8511, Japan; Not yet recruiting

Osaka 558-8558, Japan; Not yet recruiting

Basel 4031, Switzerland; Recruiting

Bern 3010, Switzerland; Not yet recruiting

Genève 1211, Switzerland; Recruiting

Luzern 6000, Switzerland; Recruiting

St. Gallen 9007, Switzerland; Terminated

Medellín, ANTIOQUIA, Colombia; Not yet recruiting

Nagaya, Aichi 457-8510, Japan; Not yet recruiting

Nagoya, Aichi 454-0933, Japan; Not yet recruiting

Birmingham, Alabama 35209, United States; Recruiting

Tuscaloosa, Alabama 35406, United States; Recruiting

Medellín, Antioquia, Colombia; Not yet recruiting

Karlsruhe, Baden-Württemberg 76133, Germany; Recruiting

Mannheim, Baden-Württemberg 68167, Germany; Recruiting

Heidelberg, Baden-Württemberg 69120, Germany; Recruiting

Augsburg, Bayern 86156, Germany; Recruiting

Erlangen, Bayern 91054, Germany; Recruiting

München, Bayern 81377, Germany; Not yet recruiting

München, Bayern 81675, Germany; Not yet recruiting

Potsdam, Brandenburg 14467, Germany; Not yet recruiting

Newport Beach, California 92663, United States; Recruiting

Los Gatos, California 95032, United States; Recruiting

Santa Rosa, California 95403, United States; Terminated

Jacksonville, Florida 32209, United States; Not yet recruiting

Frankfurt, Hessen 60488, Germany; Recruiting

Kobe, Hyogo 654-0047, Japan; Recruiting

Himeji, Hyogo 670-8520, Japan; Recruiting

Himeji, Hyogo 672-8501, Japan; Recruiting

Kobe, Hyogo 650-0047, Japan; Recruiting

Evanston, Illinois 60201-1613, United States; Not yet recruiting

Atchison, Kansas 66002, United States; Not yet recruiting

Topeka, Kansas 66604, United States; Terminated

Indore, MP 252002, India; Not yet recruiting

Mumbai, Maharashtra 400004, India; Not yet recruiting

Brockton, Massachusetts 02301, United States; Terminated

St. Louis, Missouri 63110, United States; Recruiting

Sydney, New South Wales 2050, Australia; Not yet recruiting

Sydney, New South Wales 2217, Australia; Not yet recruiting

Sydney, New South Wales 2145, Australia; Not yet recruiting

Kingston, New York 12401, United States; Not yet recruiting

New York, New York 10003, United States; Not yet recruiting

Hannover, Niedersachsen 30625, Germany; Not yet recruiting

Tulln, Niederösterreich 3430, Austria; Not yet recruiting

Köln, Nordrhein-Westfalen 50931, Germany; Not yet recruiting

Dortmund, Nordrhein-Westfalen 44263, Germany; Recruiting

Durham, North Carolina 27710, United States; Not yet recruiting

Kishiwada, Osaka 596-8522, Japan; Recruiting

Philadelphia, Pennsylvania 19104, United States; Recruiting

Pittsburgh, Pennsylvania 15212, United States; Not yet recruiting

Providence, Rhode Island 02903-4900, United States; Recruiting

Homburg, Saarland 66421, Germany; Recruiting

Leipzig, Sachsen 04103, Germany; Not yet recruiting

Dresden, Sachsen 01307, Germany; Recruiting

Kiel, Schleswig-Holstein 24105, Germany; Recruiting

Charleston, South Carolina 29425, United States; Not yet recruiting

Graz, Steiermark 8036, Austria; Not yet recruiting

Erfurt, Thüringen 99089, Germany; Not yet recruiting

Melbourne, Victoria 3168, Australia; Recruiting

Seattle, Washington 98195, United States; Recruiting

Shimonoseki, Yamaguchi 750-0061, Japan; Recruiting

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Starting date: June 2008
Ending date: June 2009
Last updated: January 12, 2009