jRCT2080222933已完成3 期
Randomized open multicenter study to assess efficacy (for patient outcome) and safety of a single dose (i.v.) of NMK36 in patients with clinically- suspected glioma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 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
- Randomized, Parall-group Comparison, Open-label
- 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 with diagnosed as suspected low/high-grade glioma by the clinical sign/course and MRI exam and scheduled for the surgical resection of the tumor.
排除标准
- •Patients who had received or under treatment of glioma or had received needle biopsy for diagnosis.
- •Patients who had 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
- •Patients who received or are to receive 11C-MET-PET during trial.
结局指标
主要结局
safety
subjective/objective symptoms, electrocardiogram exam, vital signs, clinical tests
efficacy
时间窗: 9months
comparison of Progression Free Survival rate during 9months in patients with clinically- suspected high-grade glioma between groups
次要结局
- Progression Free Survival rate during 6months(6months)
- rate that NMK36-PET contributes to decide or changes the area of tumor-resection
- Progression Free Survival rate during 9months other than suspected high-grade glioma(9months)
- Progression-Free Survival periods
- positive-predictive value of PET imaging in the regions which are not visualized clearly by contrast T1-weighted MRI
- sensitivity and specificity of NMK36-PET for collected samples
- semiquantitative index to detect tumor-extent
- comparison of pathological findings between the regions which NMK36-PET visuallized or not
- rate of patients with diagnosed as histopathologically high-grade glioma in patients with suspected low-grade glioma
- inter-reader concordance rate for the reading of NMK36 images
研究者
研究点 (1)
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