Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
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.