NCT02034708

Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors

Intra-individual Cross-over Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/ Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Brain Tumor

Interventions

Type	Name	Description
DRUG	Dotarem®	Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
DRUG	Gadovist®/Gadavist®	Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-01-13
• Last updated: 2016-12-30
• Results posted: 2016-10-25

Locations

32 sites across 4 countries: United States, Colombia, Mexico, South Korea