drugset / Trial / NCT02070380

Crossover Comparison of MultiHance and Dotarem

NCT02070380 ↗

Phase 4 Completed 179 enrolled Bracco Diagnostics, Inc
RandomizedCrossoverTriple-blindDiagnostic

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.

Timeline

Start
2014-02
Primary completion
2015-03
Completion
2015-03

Outcome

Mixed primary results

registry p <0.0001; ∆Percentage MH better minus DM better 47.6 (95% CI 34.5 to 60.7); Wilcoxon signed-rank test. NCT02070380 ↗

registry p = 0.1295; ∆Percentage MH better minus DM better 7.3 (95% CI -2.0 to 16.5); Wilcoxon signed-rank test. NCT02070380 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadobenate dimeglumine Diagnostic / imaging agent 0.05 mmol —
Subject Gadobenate dimeglumine Diagnostic / imaging agent 0.1 mmol —
Subject Gadoterate meglumine Diagnostic / imaging agent 0.1 mmol —

Indications