drugset / Trial / NCT01613417

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

NCT01613417

Phase 4 Completed 229 enrolled Bracco Diagnostics, Inc
RandomizedCrossoverTriple-blindDiagnostic

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.

Timeline

Start
2012-08
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gadobutrol Diagnostic / imaging agent 0.1 mmol Intravenous
Comparator Gadoteridol Diagnostic / imaging agent 0.1 mmol Intravenous

Indications