Trial Condition(s):
Diagnostic Imaging, Central nervous system diseases
Safety and efficacy of gadobutrol 1.0 molar (Gadavist) in patients for central nervous system (CNS) imaging
Bayer Identifier:
91681
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Is at least 18 years of age - Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure - Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate
Exclusion Criteria
- Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents - Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents - Has severe cardiovascular disease (eg, known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)- Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Augsburg, Germany, 865156 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erlangen, Germany, 91054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60488 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg, Germany, 66424 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Evanston, United States, 60201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Gatos, United States, 95032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Providence, United States, 02903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlsruhe, Germany, 76133 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10117 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mannheim, Germany, 68167 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiel, Germany, 24105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50937 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Potsdam, Germany, 14467 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dortmund, Germany, 44263 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98195 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newport Beach, United States, 92658-6100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tuscaloosa, United States, 35406 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 29425 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 537-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 616-8255 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Himeji, Japan, 672-8501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shimonoseki, Japan, 750-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 558-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Westmead, Australia, 2145 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Luzern, Switzerland, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genève, Switzerland, 1211 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kingston, United States, 12401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atchison, United States, 66002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 540-0006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kishiwada, Japan, 596-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 654-0048 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Himeji, Japan, 670-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 650-0047 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 457-8510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 454-0933 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clayton, Australia, 3168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cali, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded ReadersTimeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
Secondary Outcome
- Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Average ReaderTimeframe: Up to 2 hours after injection of gadoteridol
- Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Average ReaderTimeframe: Up to 2 hours after injection of gadoteridol
- 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 ReaderTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average ReaderTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Percentage of participants with more lesions detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded ReadersTimeframe: Up to 2 hours after injection of gadobutrol
- Percentage of participants with more lesions detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average ReaderTimeframe: Up to 2 hours after injection of gadoteridol
- Percentage of participants with more lesions detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average ReaderTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- 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 InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadoteridol
- Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadoteridol
- 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 InvestigatorTimeframe: Up to 2 hours after injection of gadoteridol
- Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadoteridol
- 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 InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- 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 InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- 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 InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Majority ReaderTimeframe: Up to 2 hours after injection of gadobutrol
- Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Majority ReaderTimeframe: Up to 2 hours after injection of gadoteridol
- Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadoteridol
- 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 ReaderTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- 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 InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadoteridol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadoteridol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadoteridol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadoteridol
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadoteridol
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadoteridol
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadoteridol
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadoteridol
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadoteridol
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by average readerTimeframe: Up to 2 hours after injection of gadobutrol
- Diagnostic confidence for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by average readerTimeframe: Up to 2 hours after injection of gadoteridol
- Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by average readerTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Diagnostic confidence for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadoteridol
- Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Comparison of image quality between gadobutrol and gadoteridol by blinded readersTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Percentage of participants for which blinded readers said image quality was higherTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Assessment of the number of contrast-enhanced lesions for gadobutrol and gadoteridol by blinded readersTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
- Percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced for gadobutrol and gadoteridol by blinded readersTimeframe: Up to 2 hours after injection of gadobutrol or gadoteridol
Additional Information
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