Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
Status:
COMPLETED
Trial end date:
2025-03-26
Target enrollment:
Participant gender:
Summary
This trial conducted in Japan includes 2 different cohorts of patients: adult patients and pediatric patients with two different designs.
* The cohort of adult patients has a prospective, multi-center, randomized, double-blind, controlled, and cross-over design.
* The cohort of pediatric patients has a prospective, multi-center, non-randomized, open-label and single arm design.
Primary objective 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 is applicable for adult patients referred for contrast-enhanced MRI of Central Nervous System (CNS) or Body regions.