Early Feasibility Study of an Open-Field Handheld Wireless Fluorecence Imaging System for Detection of Sentinel Lymph Nodes in Women With Cervical and Uterine Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- The ability to detect sentinel lymph nodes.
研究概览
简要总结
This is an early feasibility study to evaluate the device functionality of an open-field handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women with cervical and uterine cancers who underwent open surgery.
详细描述
This study was designed to clinically evaluate the functionality of an prototype of our near-infrared fluorescence device named Easy Light. In brief, this device is an open-field handheld wireless fluorecence imaging system that allows real-time visualization of fluorescent dyes such as indocyanine green (ICG) using smartphones and tablets. The handheld is a rechargeable device responsible for excitation of the operative field with infra-red lighting and for capturing the fluorescence emitted by de fluorescent dye to be visualized via wi-fi in the smartphones and tablets using a pre-installed application software. Following the standards of near-infrared fluorescence for detection of sentinel lymph nodes in gynecological malignancies, the hypothesis was the identification of sentinel lymph nodes after lymphatic mapping by interstitial indocyanine green injection in the cervix was feasible with the use of our device named Easy Light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with biopsy-proven cervical or uterine cancers;
- •Clinical stage I or II, according to FIGO - The International Federation of Gynecology and Obstetrics;
- •Indication for sentinel lymph node biopsy with or without complementary lymphadenectomy by her medical assistant;
- •Performance status of 0-2;
- •No synchronous malignancies or previous oncological treatments such as radiation or major abdominal surgery;
- •Absence of neuro-psychiatric disorders, apparent or confirmed infections, history of drug allergies, limiting obesity for surgery, and pregnancy or breast feeding;
- •Appropriated cardio-respiratory, hepato-renal and hematological reserves;
- •Signing of the Consent Form.
排除标准
- •Perioperative impossibility to inject the fluorescent dye indocyanine green in the cervical region due to any locorregional reason.
结局指标
主要结局
The ability to detect sentinel lymph nodes.
时间窗: Intraoperativelly
The ability to detect at least one sentinel lymph node per patient during open surgeries.
次要结局
未报告次要终点
研究者
Thales Paulo Batista
Consulting
Professor Fernando Figueira Integral Medicine Institute