Gadolinium contrast (HRS-9231) for MRI of brain and spinal cord 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)

This study will test whether a new gadolinium contrast agent called HRS-9231 helps doctors see CNS lesions as well as the standard agent gadobutrol and whether contrast-enhanced MRI with HRS-9231 shows better lesion visibility than unenhanced MRI in adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07275814 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study compares the new gadolinium-based contrast agent HRS-9231 with the approved agent gadobutrol in adults who need CNS MRI for known or suspected enhancing lesions. Participants will receive contrast-enhanced MRI with either HRS-9231 or gadobutrol to test non-inferiority in lesion visualization scores, and contrast-enhanced scans will also be compared to unenhanced MRI using each patient as their own control to test for superiority. Safety monitoring, including renal function checks, and population pharmacokinetic sampling will be performed. Patients with severe renal impairment, MRI contraindications, pregnancy, or other exclusions will not be enrolled.

Who should consider this trial

Good fit: Adults (age ≥18) with at least one known or highly suspected enhancing CNS lesion who can undergo MRI and have acceptable kidney function are the ideal candidates.

Not a fit: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2), acute kidney injury, MRI contraindications (e.g., pacemaker, certain metal implants, severe claustrophobia), severe allergies, pregnancy or breastfeeding, or other unstable conditions are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, HRS-9231 could provide an alternative gadolinium contrast that gives equal or improved lesion visibility on CNS MRI, potentially improving diagnostic clarity and treatment decisions.

How similar studies have performed: Gadolinium-based agents like gadobutrol are well established for CNS imaging, and prior non-inferiority trials of alternative GBCAs have generally shown comparable lesion visualization, so this approach follows existing successful patterns.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Fei Shi

Conditions For Contrast-enhanced Magnetic Resonance Imaging of Central Nervous System Lesions