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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 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 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.
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
- •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.
排除标准
- •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.
研究组 & 干预措施
Gadobutrol + HRS-9231 Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
干预措施: HRS-9231 Injection (Drug)
HRS-9231 + Gadobutrol Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
干预措施: HRS-9231 Injection (Drug)
HRS-9231 + Gadobutrol Group
HRS-9231 enhanced MRI then Gadobutrol enhanced MRI.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Gadobutrol + HRS-9231 Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Gadobutrol + HRS-9231 Group
Gadobutrol enhanced MRI then HRS-9231 enhanced MRI.
干预措施: Gadobutrol Injection (Drug)
HRS-9231 + Gadobutrol 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.)
- 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.)
- Number and size of lesions in MRI images after receiving HRS-9231.(Day 1 after procedure.)
- Population pharmacokinetic parameters - apparent volume of distribution.(Day 1 after procedure.)
- Specificity for lesion detection on MRI images obtained with HRS-9231.(Day 1 after procedure.)
- Number and size of lesions in MRI images after receiving the control drug.(Day 1 after procedure.)
- Population pharmacokinetic parameters - clearance.(Day 1 after procedure.)
- Specificity for lesion detection on MRI images obtained with gadobutrol.(Day 1 after procedure.)
- HRS-9231 plasma concentration.(Day 1 after procedure.)
- Sensitivity for lesion detection on MRI images obtained with HRS-9231.(Day 1 after procedure.)
- Sensitivity for lesion detection on MRI images obtained with gadobutrol.(Day 1 after procedure.)