jRCT2080222240已完成2 期
Open-label study to assess efficacy and safety of a single dose (i.v.) of NMK36 in subjects with high / low- grade glioma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Non-randomized, Open-label, Uncontrolled
- 主要目的
- Diagnostic Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who were clinicaly-suspected with high / low- grade glioma by the clinical sign / course and MRI exam are to have the surgical removal of the tumor.
排除标准
- •Patients who received treatment for glioma.
- •Patients who received chemotherapy for malignant tumor within the last 5 years.
- •Patients who are pregnant, lactating or possibly pregnant.
- •Patients who have hepatic or renal dysfunction.
- •Patients with Karnofsky performance status below 40%.
结局指标
主要结局
safety
subjective/objective symptoms, electrocardiogram exam, vital signs, clinical tests
efficacy
positive-predictive value of PET imaging in the regions which are not visualized by contrast T1-weighted MRI
次要结局
未报告次要终点
研究者
研究点 (1)
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