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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 m
- •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.
研究组 & 干预措施
HRS-9231 + Gadobutrol Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
干预措施: Gadobutrol Injection (Drug)
HRS-9231 + Gadobutrol Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
干预措施: HRS-9231 Injection (Drug)
Gadobutrol + HRS-9231 Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
干预措施: HRS-9231 Injection (Drug)
HRS-9231 + Gadobutrol Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Gadobutrol + HRS-9231 Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Gadobutrol + HRS-9231 Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
干预措施: Gadobutrol Injection (Drug)
结局指标
主要结局
To compare the lesion visualization scores (border delineation) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
时间窗: Day 1 after procedure.
To compare the lesion visualization scores (internal morphology) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
时间窗: Day 1 after procedure.
To compare the lesion visualization scores (degree of contrast enhancement) of HRS-9231-enhanced with gadobutrol-enhanced MRI.
时间窗: Day 1 after procedure.
次要结局
- HRS-9231 plasma concentration.(Day 1 after procedure.)
- Population pharmacokinetic parameters - clearance.(Day 1 after procedure.)
- 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.)
- 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.)