Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Detection rate of sentinel lymph node
研究概览
简要总结
investigators aimed to determine the validity of our novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of laparoscopic SLN mapping
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age, married, without childbearing requirements at the time of consent.
- •FIGO stage IA1-IIB cervical squamous cell 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
研究组 & 干预措施
TMTP1
The TMTP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of this TMTP1-ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.
干预措施: TMTP1-ICG (Drug)
ICG
The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.
干预措施: ICG (Drug)
结局指标
主要结局
Detection rate of sentinel lymph node
时间窗: 1 day
Detection of sentinel lymph node per patient
次要结局
- Specificity(7 days)
- Incidence of adverse events(7 days)
- Sensitivity(7 days)
研究者
Ding Ma
Director
Huazhong University of Science and Technology