Primary Brain Tumor Clinical Trial
Official title:
Intra-individual Cross-over Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/ Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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