Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

Summary

GDX-44-014 - GDX-101 study was conducted in Japan including 2 cohorts (adult cohort for adult population and pediatric cohort for pediatric population), with different designs: * The adult cohort had a prospective, multi-center, randomized, double-blind, controlled, and cross-over design. * The pediatric cohort had a prospective, multi-center, non-randomized, open-label and single arm design. The primary objective was to demonstrate the non-inferiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg body weight (BW) compared to gadobutrol-enhanced MRI at 0.1 mmol/kg BW in terms of lesion visualization for adult patients referred for contrast-enhanced MRI of Central Nervous System (CNS) or Body regions.

Timeline

Start

2023-07-21

Primary completion

2025-05-06

Completion

2025-05-06

Drugs

Indications