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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00709852




Registration number
NCT00709852
Ethics application status
Date submitted
1/07/2008
Date registered
3/07/2008
Date last updated
30/12/2014

Titles & IDs
Public title
Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
Scientific 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)
Secondary ID [1] 0 0
2007-004746-33
Secondary ID [2] 0 0
91681
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diagnostic Imaging 0 0
Central Nervous System Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Treatment: Drugs - Gadoteridol (ProHance)

Experimental: Gadobutrol then Gadoteridol - 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.

Experimental: Gadoteridol then Gadobutrol - 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: Drugs: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)

Treatment: Drugs: Gadoteridol (ProHance)
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [3] 0 0
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)
Timepoint [3] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [5] 0 0
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers
Timepoint [5] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [6] 0 0
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)
Timepoint [6] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [7] 0 0
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)
Timepoint [7] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [8] 0 0
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)
Timepoint [8] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [9] 0 0
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)
Timepoint [9] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [10] 0 0
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)
Timepoint [10] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [11] 0 0
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)
Timepoint [11] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [12] 0 0
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)
Timepoint [12] 0 0
Up to 2 hours after injection of gadobutrol
Primary outcome [13] 0 0
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)
Timepoint [13] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [2] 0 0
Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
Timepoint [2] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [4] 0 0
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
Timepoint [4] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [5] 0 0
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers
Timepoint [5] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [6] 0 0
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader
Timepoint [6] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [7] 0 0
Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
Timepoint [7] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [8] 0 0
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [8] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [9] 0 0
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [9] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [12] 0 0
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [12] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [13] 0 0
Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [13] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [17] 0 0
Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Timepoint [17] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [20] 0 0
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Timepoint [20] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [21] 0 0
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [21] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [22] 0 0
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Timepoint [22] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [23] 0 0
Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [23] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [26] 0 0
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
Timepoint [26] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [27] 0 0
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
Timepoint [27] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [28] 0 0
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
Timepoint [28] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [29] 0 0
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
Timepoint [29] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [30] 0 0
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
Timepoint [30] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [31] 0 0
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
Timepoint [31] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [32] 0 0
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
Timepoint [32] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [33] 0 0
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
Timepoint [33] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [34] 0 0
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
Timepoint [34] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [35] 0 0
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Timepoint [35] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [36] 0 0
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Timepoint [36] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [37] 0 0
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Timepoint [37] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [38] 0 0
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [38] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [39] 0 0
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [39] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [40] 0 0
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [40] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [41] 0 0
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Timepoint [41] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [42] 0 0
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Timepoint [42] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [43] 0 0
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Timepoint [43] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [44] 0 0
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [44] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [45] 0 0
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [45] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [46] 0 0
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [46] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [47] 0 0
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
Timepoint [47] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [48] 0 0
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
Timepoint [48] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [49] 0 0
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
Timepoint [49] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [50] 0 0
Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Timepoint [50] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [51] 0 0
Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Timepoint [51] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [52] 0 0
Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Timepoint [52] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [53] 0 0
Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader
Timepoint [53] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [54] 0 0
Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
Timepoint [54] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [55] 0 0
Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
Timepoint [55] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [56] 0 0
Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [56] 0 0
Up to 2 hours after injection of gadobutrol
Secondary outcome [57] 0 0
Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Timepoint [57] 0 0
Up to 2 hours after injection of gadoteridol
Secondary outcome [58] 0 0
Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Timepoint [58] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [59] 0 0
Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers
Timepoint [59] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [60] 0 0
Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher
Timepoint [60] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [61] 0 0
Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers
Timepoint [61] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol
Secondary outcome [62] 0 0
Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers
Timepoint [62] 0 0
Up to 2 hours after injection of gadobutrol or gadoteridol

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
402
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Austria
State/province [18] 0 0
Niederösterreich
Country [19] 0 0
Austria
State/province [19] 0 0
Oberösterreich
Country [20] 0 0
Austria
State/province [20] 0 0
Steiermark
Country [21] 0 0
Austria
State/province [21] 0 0
Wien
Country [22] 0 0
Colombia
State/province [22] 0 0
Antioquia
Country [23] 0 0
Colombia
State/province [23] 0 0
Cundinamarca
Country [24] 0 0
Colombia
State/province [24] 0 0
Valle del Cauca
Country [25] 0 0
Colombia
State/province [25] 0 0
Medellín
Country [26] 0 0
Germany
State/province [26] 0 0
Baden-Württemberg
Country [27] 0 0
Germany
State/province [27] 0 0
Bayern
Country [28] 0 0
Germany
State/province [28] 0 0
Brandenburg
Country [29] 0 0
Germany
State/province [29] 0 0
Hessen
Country [30] 0 0
Germany
State/province [30] 0 0
Niedersachsen
Country [31] 0 0
Germany
State/province [31] 0 0
Nordrhein-Westfalen
Country [32] 0 0
Germany
State/province [32] 0 0
Saarland
Country [33] 0 0
Germany
State/province [33] 0 0
Sachsen
Country [34] 0 0
Germany
State/province [34] 0 0
Schleswig-Holstein
Country [35] 0 0
Germany
State/province [35] 0 0
Thüringen
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Hamburg
Country [38] 0 0
India
State/province [38] 0 0
Madhya Pradesh
Country [39] 0 0
India
State/province [39] 0 0
Maharashtra
Country [40] 0 0
India
State/province [40] 0 0
Lucknow
Country [41] 0 0
India
State/province [41] 0 0
Mumbai
Country [42] 0 0
Japan
State/province [42] 0 0
Aichi
Country [43] 0 0
Japan
State/province [43] 0 0
Hyogo
Country [44] 0 0
Japan
State/province [44] 0 0
Osaka
Country [45] 0 0
Japan
State/province [45] 0 0
Yamaguchi
Country [46] 0 0
Japan
State/province [46] 0 0
Kyoto
Country [47] 0 0
Switzerland
State/province [47] 0 0
Basel-Stadt
Country [48] 0 0
Switzerland
State/province [48] 0 0
Sankt Gallen
Country [49] 0 0
Switzerland
State/province [49] 0 0
Bern
Country [50] 0 0
Switzerland
State/province [50] 0 0
Genève
Country [51] 0 0
Switzerland
State/province [51] 0 0
Luzern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00709852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00709852