Overview

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

Status:
RECRUITING

Trial end date:
2026-03-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to demonstrate that, in patients requiring CNS MRI examinations, contrast-enhanced MRI with HRS-9231 is superior to unenhanced MRI in lesion visualization scores using the patients as their own controls and show that, in patients requiring CNS MRI examinations, HRS-9231 is non-inferior to Gadobutrol in lesion visualization scores; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects.

Phase:

PHASE3

Details

Lead Sponsor:

Shanghai Shengdi Pharmaceutical Co., Ltd

Treatments:

gadobutrol
Magnetic Resonance Imaging