NCT07275723

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)

Interventions

Type	Name	Description
DRUG	HRS-9231 Injection	HRS-9231 injection.
DRUG	Gadobutrol Injection	Gadobutrol injection.
DEVICE	Magnetic Resonance Imaging (MRI)	Magnetic Resonance Imaging (MRI).

Timeline

• Start date: 2025-11-14
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2025-12-10
• Last updated: 2026-04-06

Locations

2 sites across 1 country: China