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.

Study Overview

• Status: Recruiting
• Conditions: For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
• Intervention / Treatment: Drug: HRS-9231 Injection; Drug: Gadobutrol Injection; Device: Magnetic Resonance Imaging (MRI)

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Fei Shi; Phone Number: +86-021-61600276; Email: fei.shi@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Principal Investigator: Nan Hong
      • Contact: Nan Hong; Phone Number: +86-010-88326666; Email: hongnan@pkuph.edu.cn
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Meiyun Wang; Phone Number: +86-0371-65580014; Email: mywang@ha.edu.cn
      • Principal Investigator: Meiyun Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gadobutrol + HRS-9231 Group; HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.	Drug: HRS-9231 Injection; HRS-9231 injection.; Drug: Gadobutrol Injection; Gadobutrol injection.; Device: Magnetic Resonance Imaging (MRI); Magnetic Resonance Imaging (MRI).
Experimental: HRS-9231 + Gadobutrol Group; Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.	Drug: HRS-9231 Injection; HRS-9231 injection.; Drug: Gadobutrol Injection; Gadobutrol injection.; Device: Magnetic Resonance Imaging (MRI); Magnetic Resonance Imaging (MRI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.	Day 1 after procedure.
To compare the lesion visualization scores (internal morphology) of HRS-9231-enhanced with gadobutrol-enhanced MRI.	Day 1 after procedure.
To compare the lesion visualization scores (degree of contrast enhancement) of HRS-9231-enhanced with gadobutrol-enhanced MRI.	Day 1 after procedure.

Secondary Outcome Measures

Outcome Measure	Time Frame
Number, size, and location of CNS lesions in MRI images after receiving HRS-9231.	Day 1 after procedure.
Number, size, and location of CNS lesions in MRI images after receiving gadobutrol.	Day 1 after procedure.
HRS-9231 plasma concentration.	Day 1 after procedure.
Population pharmacokinetic parameters - clearance.	Day 1 after procedure.
Population pharmacokinetic parameters - apparent volume of distribution.	Day 1 after procedure.
To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI.	Day 1 after procedure.
Overall diagnostic preference for CNS lesions on MRI images of HRS-9231 and gadobutrol.	Day 1 after procedure.
Diagnostic confidence of MRI images of HRS-9231 and gadobutrol.	Day 1 after procedure.
Technical adequacy of MRI images of HRS-9231 and gadobutrol.	Day 1 after procedure.

Collaborators and Investigators

• Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging; gadobutrol
• Other Study ID Numbers: HRS-9231-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No