NCT03549195Unknown不适用
Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Detection rate of micro-metastasis sentinel lymph node
研究概览
简要总结
Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Without childbearing requirements at the time of consent.
- •FIGO stage IB1, IIA1 cervical cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
- •Subject has provided written informed consent.
排除标准
- •Breast-feeding or pregnant.
- •Ongoing participation in another clinical trial with an investigational drug with 3 months
- •Own allergy towards ICG and/or alcohol
- •Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
- •Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency
结局指标
主要结局
Detection rate of micro-metastasis sentinel lymph node
时间窗: 7 days
Detection of micro-metastasis sentinel lymph node per patient
次要结局
- Sensitivity(7 days)
- Incidence of adverse events(7 days)
- Specificity(7 days)
研究者
Ding Ma
Director
Huazhong University of Science and Technology
研究点 (1)
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