日本人成人および小児における磁気共鳴画像（MRI）検査におけるガドピクレノールの評価

基本情報

NCT ID

NCT06010173

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

240

治験依頼者名

Guerbet

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (27)