Clinical Trial

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

Completed Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-07-01
minor Completion pushed: 2026-05 -> 2026-06-09 2026-07-01
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-12
Trial Details
NCT Number NCT07275723
Lead Sponsor Shanghai Shengdi Pharmaceutical Co., Ltd
Conditions For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)
Enrollment 309 participants
Start Date 2025-11-14
Primary Completion 2026-04-18 (estimated)
Study Completion 2026-06-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-30