NCT03407495已完成2 期
A Phase II, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Clinical Validity and Safety of IOP Injection for Magnetic Resonance Imaging (MRI) Contrast Agent in Hepatocellular Carcinoma (HCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- The Sensitivity and specificity of IOP-enhanced MRI
研究概览
简要总结
This study is an exploratory study aiming to collect data on sensitivity and positive predictive value of IOP-enhanced (MPB-1523) MRI compared to dynamic multiphase MDCT for the detection of HCC.
详细描述
The planned duration of the clinical study for individual subjects is up to 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Subjects ≥18 years of age
- •Patients with suspected HCC scheduled for partial hepatic resection.
- •Presenting with 1 to a maximum of 5 hepatic nodule(s) of equal or more than 1 cm (long axis) previously identified and characterized through multi-phase contrast enhanced CT.
- •Subjects or their partners must use a highly effective method of contraception starting from at least one menstrual cycle prior to starting study drug and till 30 days after the last dose of study drug.
排除标准
- •Subjects who received any previous treatment for HCC.
- •Subjects with a serious allergic history or known allergy of other contrast agent.
- •Subjects with a positive HIV test.
- •Subjects with severe renal insufficiency
- •Subjects with severe liver disease[HCV].
- •Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.
- •Subject with mechanically, electrically or magnetically-activated implanted device or any metal in their body which cannot be removed.
- •Subjects who have participated in other investigational trials within 30 days prior to study enrollment.
- •Female subjects who are pregnant or breastfeeding.
- •Subjects who are clinically unstable and whose clinical course during the screening period is unpredictable.
研究组 & 干预措施
single arm: IOP injection (MPB-1523)
Experimental
single group treatment
干预措施: IOP Injection (MPB-1523) (Drug)
结局指标
主要结局
The Sensitivity and specificity of IOP-enhanced MRI
时间窗: After IOP injection administration within 60 mins
Sensitivity and specificity of IOP-enhanced MRI will be calculated using dynamic multiphase MDCT as the reference standard. Confirmation of the diagnosis of HCC lesions will be obtained by surgery.
次要结局
- The Number of lesions detected in liver(After IOP injection administration within 60 mins)
- Optimal time to perform a MRI scan after injection of IOP(After IOP injection administration within 60 mins)
- The size of lesions detected in liver(After IOP injection administration within 60 mins)
研究者
研究点 (5)
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