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)

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.

Inclusion Criteria:

1. Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements.
2. Age ≥ 18 years, male or female.
3. 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 Criteria:

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