HRS-9231 Injection
DrugHRS-9231 injection.
Completed
NCT Number: NCT07275814
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
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Peking University People's Hospital, Beijing, Beijing Municipality, China
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
Gadobutrol Injection
DrugGadobutrol injection.
Magnetic Resonance Imaging (MRI)
DeviceMagnetic Resonance Imaging (MRI).
Primary outcomes
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To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time frame: Day 1 after procedure.
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To compare the lesion visualization scores (internal morphology) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time frame: Day 1 after procedure.
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To compare the lesion visualization scores (degree of contrast enhancement) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Time frame: Day 1 after procedure.
Secondary outcomes
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To compare the lesion visualization scores of HRS-9231-enhanced with unenhanced MRI.
Time frame: Day 1 after procedure.
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Number, size, and location of CNS lesions in MRI images after receiving HRS-9231.
Time frame: Day 1 after procedure.
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Number, size, and location of CNS lesions in MRI images after receiving gadobutrol.
Time frame: Day 1 after procedure.
-
HRS-9231 plasma concentration.
Time frame: Day 1 after procedure.
-
Population pharmacokinetic parameters - clearance.
Time frame: Day 1 after procedure.
-
Population pharmacokinetic parameters - apparent volume of distribution.
Time frame: Day 1 after procedure.
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Overall diagnostic preference for CNS lesions on MRI images of HRS-9231 and gadobutrol.
Time frame: Day 1 after procedure.
-
Diagnostic confidence of MRI images of HRS-9231 and gadobutrol.
Time frame: Day 1 after procedure.
-
Technical adequacy of MRI images of HRS-9231 and gadobutrol.
Time frame: Day 1 after procedure.
Sponsors and collaborators
Lead sponsor
Shanghai Shengdi Pharmaceutical Co., Ltd
Industry
Registry information
Official study title
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)
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 10, 2025
- Registry last updated
- Jun 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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