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

Central Nervous System Diseases Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709852
• Other study ID #: 91681
• Secondary ID: 2007-004746-3331
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2008
• Last updated: December 8, 2014
• Start date: June 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Issues on safety will be addressed in Adverse Events section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Diagnostic Imaging
• Nervous System Diseases

Intervention

Drug:
• Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
• Gadoteridol (ProHance)
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St George Hospital	Kogarah	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	LNK Wagner Jauregg	Linz	Oberösterreich
Austria	Landeskrankenhaus Donauregion Tulln	Tulln	Niederösterreich
Austria	Allgemeines Krankenhaus der Stadt Wien Universitätskliniken	Wien
Colombia	Fundación Santa Fe de Bogotá - Hospital Universitario	Bogotá	Cundinamarca
Colombia	DIME Clinica Neurocardiovascular S.A.	Cali	Valle del Cauca
Colombia	Centro de Diagnostico Medico	Medellín
Colombia	Fundación Instituto de Alta tecnología médica de Antioquia	Medellín	Antioquia
Germany	Zentralklinikum Augsburg	Augsburg	Bayern
Germany	Universitätsklinikum Charite zu Berlin	Berlin
Germany	Medizinische Einrichtungen der Universität Bonn	Bonn	Nordrhein-Westfalen
Germany	Medizinisches Versorgungszentrum Prof. Dr. D. Uhlenbrock	Dortmund	Nordrhein-Westfalen
Germany	Medizinische Fakultät Carl Gustav Carus	Dresden	Sachsen
Germany	HELIOS Klinikum Erfurt GmbH	Erfurt	Thüringen
Germany	Universitätsklinikum Erlangen	Erlangen	Bayern
Germany	Krankenhaus Nordwest	Frankfurt	Hessen
Germany	Universitätsklinikum Hamburg Eppendorf (UKE)	Hamburg
Germany	Kliniken der Medizinischen Hochschule Hannover	Hannover	Niedersachsen
Germany	Deutsches Krebsforschungszentrum	Heidelberg	Baden-Württemberg
Germany	Universitätskliniken des Saarlandes	Homburg	Saarland
Germany	Städtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Baden-Württemberg
Germany	Klinikum der Christian-Albrechts-Universität	Kiel	Schleswig-Holstein
Germany	Universitätsklinikum Köln	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Leipzig AöR	Leipzig	Sachsen
Germany	Klinikum Mannheim gGmbH	Mannheim	Baden-Württemberg
Germany	Klinikum rechts der Isar	München	Bayern
Germany	LMU Klinikum der Universität München - Großhadern	München	Bayern
Germany	Klinikum Ernst von Bergmann	Potsdam	Brandenburg
India	CT /MRI centre	Indore	Madhya Pradesh
India	Sanjay Gandhi Post Graduate Institute of Medical Sciences	Lucknow
India	Bombay Hospital, Institute of Medical sciences	Mumbai
India	Piramal Diagnostic- Jankharia Imaging	Mumbai	Maharashtra
Japan	Himeji Central Hospital	Himeji	Hyogo
Japan	Himeji Medical Center	Himeji	Hyogo
Japan	Kishiwada Tokushukai Hospital	Kishiwada	Osaka
Japan	Institute of Biomedical Research and Innovation	Kobe	Hyogo
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Shinsuma Hospital	Kobe	Hyogo
Japan	Utano National Hospital	Kyoto
Japan	Nagoya Kyoritsu Clinic	Nagoya	Aichi
Japan	Nagoya Kyoritsu Hospital	Nagoya	Aichi
Japan	Social Insurance Chukyo Hospital	Nagoya	Aichi
Japan	Osaka General Medical Center	Osaka
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka
Japan	Osaka National Hospital	Osaka
Japan	Shimonoseki Kosei Hospital	Shimonoseki	Yamaguchi
Switzerland	Universitätsspital Basel	Basel	Basel-Stadt
Switzerland	Inselspital Bern	Bern
Switzerland	Hôpital Cantonal Universitaire de Genève	Genève
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Kantonsspital St. Gallen	St. Gallen	Sankt Gallen
United States	University of New Mexico School of Medicine	Alburquerque	New Mexico
United States	Atchison Hospital	Atchison	Kansas
United States	Johns Hopkins Hospital/Health System	Baltimore	Maryland
United States	University of Maryland Hospital System	Baltimore	Maryland
United States	West Alabama Research, Inc.	Birmingham	Alabama
United States	Shields MRI - Brockton	Brockton	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois
United States	University of Florida - Jacksonville	Jacksonville	Florida
United States	Kingston Neurological Associates, PC	Kingston	New York
United States	Los Gatos MRI	Los Gatos	California
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	NYU Hospital for Joint Diseases	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Redwood Regional Medical Group, Inc.	Santa Rosa	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Achieve Clinical Research, LLC	Tuscaloosa	Alabama
United States	VA Boston Healthcare System-West Roxbury Division	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Colombia,  Germany,  India,  Japan,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)	BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)	BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)	BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)	The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers	The blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)	BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)	BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)	BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)	The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)	BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)	BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)	BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Primary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)	The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Secondary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader	The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadoteridol	No
Secondary	Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader	The AR analysis used the mean of the values for the 3 blinded readers	Up to 2 hours after injection of gadoteridol	No
Secondary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader	The AR analysis used the mean of the values for the 3 blinded readers.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader	The AR analysis used the mean of the values for the 3 blinded readers	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers	The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another and determined the number of lesion from each.	Up to 2 hours after injection of gadobutrol	No
Secondary	Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader	The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.	Up to 2 hours after injection of gadoteridol	No
Secondary	Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader	The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Secondary	Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.	Up to 2 hours after injection of gadobutrol	No
Secondary	Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Secondary	Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol	No
Secondary	Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadoteridol	No
Secondary	Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.	Up to 2 hours after injection of gadoteridol	No
Secondary	Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadoteridol	No
Secondary	Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadoteridol	No
Secondary	Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader	The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.	Up to 2 hours after injection of gadobutrol	No
Secondary	Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.	Up to 2 hours after injection of gadobutrol	No
Secondary	Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader	The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.	Up to 2 hours after injection of gadoteridol	No
Secondary	Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.	Up to 2 hours after injection of gadoteridol	No
Secondary	Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader	The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the clinical investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.	Up to 2 hours after injection of gadobutrol	No
Secondary	Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol	No
Secondary	Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol	No
Secondary	Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.	Up to 2 hours after injection of gadoteridol	No
Secondary	Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.	Up to 2 hours after injection of gadoteridol	No
Secondary	Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.	Up to 2 hours after injection of gadoteridol	No
Secondary	Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images	The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.	Up to 2 hours after injection of gadobutrol	No
Secondary	Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol	No
Secondary	Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol	No
Secondary	Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.	Up to 2 hours after injection of gadobutrol	No
Secondary	Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol	No
Secondary	Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol	No
Secondary	Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.	Up to 2 hours after injection of gadoteridol	No
Secondary	Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee	Up to 2 hours after injection of gadoteridol	No
Secondary	Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadoteridol	No
Secondary	Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.	Up to 2 hours after injection of gadoteridol	No
Secondary	Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadoteridol	No
Secondary	Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadoteridol	No
Secondary	Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader	The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader	The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.	Up to 2 hours after injection of gadobutrol	No
Secondary	Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader	The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.	Up to 2 hours after injection of gadoteridol	No
Secondary	Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader	The BRs recorded his/her confidence in diagnosis for the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadobutrol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.	Up to 2 hours after injection of gadobutrol	No
Secondary	Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator	The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadoteridol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.	Up to 2 hours after injection of gadoteridol	No
Secondary	Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator	The investigator recorded his/her confidence in diagnosis for the combined unenhanced/gadobutrol-enhanced MR image sets and the combined unenhanced/gadoteridol MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers	The BRs evaluated the relative image quality of the gadobutrol-enhanced T1w MR images and the gadoteridol-enhanced T1w MR images in a paired fashion on a 5-point scale where 1 = image on right was worse, 2 = image on right was slightly worse, 3 = both images were the same, 4 = image on right was slightly better, and 5 = image on right was better.	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher	Percentage of participants for which blinded readers said image quality was higher	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers	Two BRs independently provided the number of contrast-enhanced lesions for gadobutrol and gadoteridol. In cases of disagreement between the readers, an independent adjudicator provided the number of contrast-enhanced lesions. The adjudicator results were used in the analysis in the cases of disagreement between the original readers	Up to 2 hours after injection of gadobutrol or gadoteridol	No
Secondary	Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers	From the quantitative signal intensity values assessed by the BR, the percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced was calculated.	Up to 2 hours after injection of gadobutrol or gadoteridol	No

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