The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment). 270 patients will be randomized between 2 arms defining the sequence of administration of the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14 days in between. Each patient will, therefore, receive two MRI during his/her participation in the study. The two arms consist in : * Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI. * Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI. Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems. MRI examinations will be evaluated centrally by blinded independent readers for the main evaluation criterion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
279
Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent
Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale: 0\. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion.
Time frame: Up to 15 days after randomization
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University of Michigan Health System
Ann Arbor, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
Winthrop University Hospital Clinical Trials Center
Mineola, New York, United States
...and 22 more locations