Intraoperative Use of Intravenous Indocyanine Green (ICG) to Assess Ovarian Perfusion Using Infrared Imaging: A Feasibility Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Assessment of ovarian perfusion after ICG administration via fluorescent imaging
研究概览
简要总结
To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery
详细描述
The purpose of this study is to determine the feasibility of intravenous ICG administration to facilitate assessments of ovarian vascular perfusion. Historically, assessment of ovarian perfusion has been performed visually or via ultrasound with Doppler evaluation. In patients with ovarian endometriomas, evidence of ovarian interstitial microvascular injury has been demonstrated similarly by the presence of low flow and high RI. The use of ICG to evaluate ovarian perfusion specifically has not been reported. The use of ICG for intraoperative perfusion assessment of the ovary could provide more information about the health of the ovary and inform the surgical approach to ovarian pathology.
ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients attending a preoperative visit at the Center for Comprehensive Gynecology who will undergo surgery.
排除标准
- •Not able to comprehend and sign a written consent
- •Patients with a history of allergy to iodides
- •Patients history of renal failure or uremia, and those on dialysis
研究组 & 干预措施
Administration of ICG
ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software. ICG will be stored at the NM Investigational Pharmacy and administered intravenously by the anesthesiologist at the direction of the surgeon during surgical procedure.
干预措施: ICG (Drug)
结局指标
主要结局
Assessment of ovarian perfusion after ICG administration via fluorescent imaging
时间窗: 2 years
The investigators will be assessing the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries by imaging. During surgery ICG will be administered intravenously via a peripheral or central line at the direction of the surgeon by the anesthesiologist. The injected amount will be a 3 mL solution of reconstituted ICG that contains a 7.5 mg dose of ICG. This will be followed by a 10 mL bolus of normal saline for injection per the manufacturer's recommendation. The total dose of dye injected should not exceed 2 mg/kg. Visibility of the ICG fluorescence should occur within 1-2 minutes with a duration of 20-120 minutes.
次要结局
未报告次要终点
研究者
Magdy Milad, MD
Chief of Minimally Invasive Gynecologic Surgery in the Department of Obstetrics and Gynecology Albert B. Gerbie, MD, Professor of Obstetrics and Gynecology Professor of Obstetrics and Gynecology (Minimally Invasive Gynecologic Surgery)
Northwestern University