Clinical Trial

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

Completed Phase 3
View on ClinicalTrials.gov →
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, HRS-9231 is non-inferior to Gadobutrol in lesion visualization scores and show 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 to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects.
Protocol Amendment History 3 changes
critical Trial completed 2026-07-01
notable Primary completion pushed: 2026-04 -> 2026-06-17 2026-07-01
minor Completion pushed: 2026-05 -> 2026-06-17 2026-07-01
Trial Details
NCT Number NCT07275814
Lead Sponsor Shanghai Shengdi Pharmaceutical Co., Ltd
Conditions For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
Enrollment 250 participants
Start Date 2025-11-17
Primary Completion 2026-06-17 (estimated)
Study Completion 2026-06-17 (estimated)
Updated on ClinicalTrials.gov 2026-06-30