At a glance
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P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
In Brief
A Phase 2 clinical trial evaluating P03277, Gadobenate dimeglumine, and 1 other intervention for CNS Lesion and Blood Brain Barrier Defect. Completed, enrolled 312 participants across 28 sites in 8 countries.
Detailed Summary
The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose. This was a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with known or highly suspected focal areas of disruption of the Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.
Study Details
Timeline
Interventions
Single intravenous (IV) bolus injection at a rate of 2 mL/second
Single IV bolus injection at a rate of 2 mL/second