A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imag… (NCT07275814) | Clinical Trial Compass
RecruitingPhase 3
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
China250 participantsStarted 2025-11-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Timeframe: Day 1 after procedure.
2
To compare the lesion visualization scores (internal morphology) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
Timeframe: Day 1 after procedure.
3
To compare the lesion visualization scores (degree of contrast enhancement) of HRS-9231-enhanced with gadobutrol-enhanced MRI.