The Feasibility and Benefits of Using Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Detection of sentinel lymph node(s)
研究概览
简要总结
Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG, sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will be identified. SLNs will be surgically removed and provided to Pathology for evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to Pathology for evaluation. A positive SLN may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women patients (>18 years of age and <90 years of age)
- •Research authorization (consent)
- •Pre-operative diagnosis of clinical Stage 1 endometrial cancer
- •Pre-operative indications of grade 3 tumor, and/or tumor size greater than 2 cm in size
- •Scheduled and consented to undergo robotic hysterectomy and surgical staging, including bilateral pelvic and para-aortic lymphadenectomy
排除标准
- •Severe coagulopathy or severe thrombocytopenia
- •Severe anemia
- •Severe cardio-pulmonary comorbidities demanding minimization of operative time
- •History of liver disease
- •Iodide allergy
- •Emergent operation
- •Additional surgical risk as determined during surgery at the discretion of the attending
- •Impaired capacity to make informed medical decisions
结局指标
主要结局
Detection of sentinel lymph node(s)
时间窗: Detection of SLNs will occur within surgery, on average this surgery will take "1-2 hours" for each participant
The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging.
次要结局
- Comparison between sentinel node status for disease and non-sentinel node disease status(Following surgery and pathological evaluation of all removed nodes, up to "1 year")
研究者
Valena Wright
Director of Minimally Invasive Gynecologic Surgery
Lahey Clinic