drugset
drugset / Trial / NCT07275814

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

NCT07275814 ↗

Phase 3 Completed 250 enrolled Shanghai Shengdi Pharmaceutical Co., Ltd
RandomizedCrossoverTriple-blindDiagnostic

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.

Timeline

Start
2025-11-17
Primary completion
2026-06-17
Completion
2026-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadobutrol Diagnostic / imaging agent — —
Subject HRS-9231 Diagnostic / imaging agent — —

Indications

No indication recorded.