jRCT2080222656已完成2 期
An open-label study to explore the efficacy of NMK36 single-dose (i.v.) injection for diagnosis of regional lymph node metastasis in subjects with prostate cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- diagnostic sensitivity of NMK36-PET/CT
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
- Male
入选标准
- •Patients with biopsy-proven prostate cancer.
- •Patients who is scheduled for regional lymph node dissection.
排除标准
- •Patients with treated prostate cancer.
- •Patients with another type of cancer.
- •Patients with bone-marrow, hepatic or renal dysfunction.
结局指标
主要结局
diagnostic sensitivity of NMK36-PET/CT
diagnostic sensitivity of NMK36-PET/CT in diagnosing the metastatic regional lymph node
次要结局
- diagnostic specificity and accuracy of NMK36-PET/CT for metastatic regional lymph node
- diagnostic sensitivity of NMK36-PET/CT for metastatic regional lymph node (subgroup analysis for size of cancer)
- comparison of the diagnosis with NMK36-PET/CT images to the pathological findings in diagnosing the metastatic regional lymph node which was not identified by contrast-enhanced CT
- range of radioactivity dose
- subjective/objective symptoms
- electrocardiogram exams
- vital signs
- laboratory tests
研究者
研究点 (1)
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