脳および／または脊髄疾患が既知または強く疑われる成人患者に対する磁気共鳴画像診断（MRI）における新規ガドリニウム造影剤（GBCA）の適切な投与量を決定するための研究

基本情報

NCT ID

NCT04307186

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

57

治験依頼者名

Bayer

概要

Researchers in this study want to find the appropriate dose of drug BAY1747846 for adults undergoing MRI for known or highly suspected brain and/or spinal cord conditions so that the image quality is similar to that of drug gadobutrol for adults undergoing MRI. MRI stands for Magnetic resonance imaging which produces body pictures created by using magnetic energy rather than x-ray energy. Both BAY1747846 and gadobutrol are medicinal products known as gadolinium-based contrast agents (GBCA) which are used in MRI examinations to provide contrast enhancement and improve imaging performance. Gadobutrol (brand name: Gadavist, Gadovist) has been approved worldwide for the diagnosis of various disorders in adult and pediatric patients. BAY1747846 is a new GBCA under development with the goal to provide similar imaging performances in MRI. Participants in this study will receive both BAY1747846 and gadobutrol with a period of 3 - 14 days in between. A MRI examination will be performed after each injection. Participant will stay in this study for 2 - 4 weeks depending on the scheduling of the visits.

対象疾患

介入

依頼者（Sponsor）

実施施設 (8)