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RecruitingPhase 3NCT07275723

A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions

A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase III Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Body Parts (Non-Central Nervous System) Magnetic Resonance Imaging (MRI)

Sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Enrollment

306 participants

Start Date

Nov 14, 2025

Study Type

INTERVENTIONAL

Conditions

For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS)

Summary

The purpose of this study is to evaluate the efficacy of HRS-9231 for Magnetic Resonance Imaging (MRI) of body regions excluding the Central Nervous System (CNS) in patients undergoing MRI examinations, using the patient's own unenhanced MRI images as a control; to demonstrate that the efficacy of HRS-9231 is not inferior to gadobutrol for lesion visualization in body MRI; to evaluate the safety of HRS-9231 for body MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in subjects undergoing body MRI examinations.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Provide written informed consent, be willing and able to comply with study requirements.
  • Age ≥18 years, male or female.
  • Subjects who are scheduled to undergo a contrast-enhanced MRI (including MRA) examination and who, within 12 months prior to signing the informed consent form, have had imaging examinations that identified at least one known or highly suspected region of enhancement abnormality or lesion in the body.

Exclusion Criteria8

  • Investigator judges unstable clinical condition or comorbidities that may affect MRI image comparability or study parameters.
  • Severe renal impairment (baseline eGFR < 30 mL/min/1.73m²) before first dose; acute kidney injury regardless of eGFR.
  • Acute kidney injury, irrespective of eGFR levels.
  • Contraindication to MRI or gadolinium contrast agents.
  • History of severe allergic reactions to drugs, contrast agents, or other allergens.
  • Severe cardiovascular disease.
  • Pregnant or breastfeeding women.
  • Any other condition deemed unsuitable by the investigator.

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Interventions

DRUGHRS-9231 Injection

HRS-9231 injection.

DRUGGadobutrol Injection

Gadobutrol injection.

DEVICEMagnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI).

Locations(2)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT07275723