ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 14
- 主要终点
- Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.
研究概览
简要总结
The purpose of this study is to find out how well ovarian sentinel lymph nodes (SLNs) can be identified with indocyanine green (ICG) dye during risk-reducing ovarian surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing surgery with the Gynecology Service at MSK.
- •Women undergoing surgery for an adnexal mass without pre-operative suspicion of high stage disease, with or without a hysterectomy
- •°For this protocol, "suspected high stage disease" will be defined as any patient with radiologic or clinical evidence of ovarian cancer which has spread outside of the ovary. Thus, only patients with an adnexal mass, or bilateral adnexal masses, are eligible.
- •Women in whom MIS surgery is converted to a laparotomy will not be excluded as both surgical approaches, MIS and open, will be utilized.
- •Women >/= 18 years of age
- •Able to provide informed consent
- •Albumin levels within normal range
排除标准
- •Current non-GYN primary malignancy
- •Prior or current history of uterine, cervical, peritoneal, or vulvovaginal malignancy
- •Ongoing anticancer therapy
- •Prior bilateral oophorectomy
- •Known severe anaphylactic iodide allergy
- •Known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction.
- •Elevated transaminases (ALT, AST) and/or Alk Phos will be evaluated by the treating physician on a case by case basis.
研究组 & 干预措施
Group 1
First group of 10 participants enrolled
干预措施: Method 1: Indocyanine green dye (Drug)
Group 2
Second group of 10 participants enrolled
干预措施: Method 2: Indocyanine green dye (Drug)
Group 3
Third group of 10 participants enrolled
干预措施: Method 3: Indocyanine green dye (Drug)
Group 4
Fourth group of 10 participants enrolled
干预措施: Method 3: Indocyanine green dye (Drug)
结局指标
主要结局
Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.
时间窗: 1 year
Evaluate for dye uptake in the regional lymphatic channels, and in the pelvic and para-aortic nodes using infrared imaging.
次要结局
未报告次要终点