NCT06731829尚未招募2 期
A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over, Dose-Escalation Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol)
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 explore the effective dose of HRS-9231 for CNS MRI; 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
- Double (Participant, 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, no gender restrictions
- •Known or highly suspected CNS lesions, with imaging showing at least one enhanced lesion
- •Scheduled for CNS contrast-enhanced MRI for clinical needs and agree to complete two contrast-enhanced MRI scans
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
- •Moderate to severe renal dysfunction, defined as aGFR < 60 mL/min
- •Contraindications to MRI, such as metallic implants or claustrophobia
- •History of severe allergies, including drugs, contrast agents, or other allergens
- •Severe liver disease or cardiovascular disease, or related abnormal test results
- •Central nervous system inflammation or recent history of stroke
- •Active infectious diseases, such as HIV, hepatitis B, or syphilis
- •Use of other contrast agents before or after study drug administration, or recent interventional treatments that may affect imaging comparability
- •Pregnancy, breastfeeding, or plans for conception, without effective contraception measures
- •Recent participation in other clinical trials or previous participation in studies involving gadolinium-based contrast agents
- •Other conditions deemed unsuitable by the investigator
研究组 & 干预措施
HRS-9231 dose 1
Experimental
干预措施: HRS-9231 (Drug)
HRS-9231 dose 2
Experimental
干预措施: HRS-9231 (Drug)
HRS-9231 dose 3
Experimental
干预措施: HRS-9231 (Drug)
Gadobutrol
Active Comparator
干预措施: Gadobutrol (Drug)
结局指标
主要结局
Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol)
时间窗: 1 day procedure
次要结局
- Medical applicability of MRI imaging for CNS lesions after receiving HRS-9231 or the control drug (Gadobutrol).(1 day procedure)
- Number, size, and location of CNS lesions in MRI images after receiving HRS-9231 or the control drug.(1 day procedure)
- Visualization scores for CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol): boundary delineation, internal morphology, and contrast enhancement.(1 day procedure)
- HRS-9231 plasma concentration and population pharmacokinetic parameters (such as clearance, apparent volume of distribution, etc.).(1 day procedure)
研究者
研究点 (1)
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