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RecruitingPhase 3NCT07275814

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

A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Enrollment

250 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements.
  • Age ≥ 18 years, male or female.
  • Have at least one known or highly suspected CNS enhancement abnormality or lesion detected by imaging (e.g., CT and MRI) within 12 months prior to ICF signing.

Exclusion Criteria8

  • Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters.
  • Severe renal impairment, defined as aGFR < 30 mL/min/1.73 m2.
  • Acute kidney injury, irrespective of eGFR levels.
  • Contraindications to MRI examinations or Gadobutrol, such as metallic implants ，pacemakers or claustrophobia.
  • History of severe allergies, including drugs, contrast agents, or other allergens.
  • Severe cardiovascular disease.
  • Female subjects who are pregnant or breastfeeding.
  • Other conditions deemed unsuitable by the investigator.

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Interventions

DRUGHRS-9231 Injection

HRS-9231 injection.

DRUGGadobutrol Injection

Gadobutrol injection.

DEVICEMagnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI).

Locations(2)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

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NCT07275814