NCT01613417

Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain

Phase IV, Double-blind, Multi-center, Randomized, Crossover Study to Compare 0.1 mmol/kg of Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.

Detailed description

Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.

Conditions

• Brain Disease

Interventions

Type	Name	Description
DRUG	gadoteridol	ProHance 0.1 mmol/kg
DRUG	gadobutrol	Gadovist/Gadavist 0.1 mmol/kg

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-06-07
• Last updated: 2015-07-01
• Results posted: 2015-06-03

Locations

1 site across 1 country: United States