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

Shanghai Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 3

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

Treatments: Device: Magnetic Resonance Imaging (MRI); Drug: HRS-9231 Injection; Drug: Gadobutrol Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07275814

HRS-9231-301

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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250 participants in 2 patient groups

Gadobutrol + HRS-9231 Group

Experimental group

Description:

HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.

Treatment:

Drug: Gadobutrol Injection

Drug: HRS-9231 Injection

Device: Magnetic Resonance Imaging (MRI)

HRS-9231 + Gadobutrol Group

Experimental group

Description:

Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.

Treatment:

Drug: Gadobutrol Injection

Drug: HRS-9231 Injection

Device: Magnetic Resonance Imaging (MRI)