Clinical Research Directory

A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions

Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd

Summary

The purpose of this study is to evaluate the efficacy of HRS-9231 for Magnetic Resonance Imaging (MRI) of body regions excluding the Central Nervous System (CNS) in patients undergoing MRI examinations, using the patient's own unenhanced MRI images as a control; to demonstrate that the efficacy of HRS-9231 is not inferior to gadobutrol for lesion visualization in body MRI; to evaluate the safety of HRS-9231 for body MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in subjects undergoing body MRI examinations.

Official title: A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase III Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Body Parts (Non-Central Nervous System) Magnetic Resonance Imaging (MRI)

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