Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
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
- •Suspicious of cervical disease required a colposcopy-directed biopsy.
- •Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
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. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.
干预措施: TMTP1 (Drug)
ICG
The ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.
干预措施: ICG (Drug)
结局指标
主要结局
Sensitivity
时间窗: 1 day
Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
次要结局
- Incidence of adverse events(7 days)
- Specificity(7 days)
研究者
Ding Ma
Director
Huazhong University of Science and Technology