NCT02070380

Crossover Comparison of MultiHance and Dotarem

Phase IV, Double Blind, Multi-Center, Randomized, Two-Arm Crossover Study to Compare 0.1 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem and 0.05 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem in MRI of the Brain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.

Detailed description

This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.

Conditions

• Brain Disease

Interventions

Type	Name	Description
DRUG	MultiHance 0.1 mmol/kg	MultiHance administered at 0.1 mmol/kg
DRUG	Dotarem	Dotarem administered at 0.1 mmol/kg
DRUG	MultiHance 0.05 mmol/kg	MultiHance administered at 0.05 mmol/kg

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-02-25
• Last updated: 2017-01-10
• Results posted: 2017-01-10

Locations

1 site across 1 country: United States