Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- fluorescence intensity of tumoral and healthy tissues after IV injection of ICG to patients with peritoneal carcinomatosis from colorectal origin.
研究概览
简要总结
The purpose of this study is to determine if Near-Infrared fluorescence imaging is an effective approach to detect the colorectal tumoral tissues and peritoneal implants in colorectal cancer patients.
详细描述
Primary objective
Evaluation of the ability of NIR imaging using ICG to demonstrate (the gross tumoral mass and/or) peritoneal metastatic " implants " in patients operated for peritoneal carcinomatosis from colorectal carcinoma
Secondary objective:
Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated per-operatively, a) in the nodes of these patients found fluorescent and removed and/or b) at the level of the fluorescent foci observed at the level of the hepatic surfaces)
Methodology:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from histo-pathologically proven colorectal carcinoma who are candidate for "open" surgery,
- •Informed consent form signed.
排除标准
- •Age less than18 years old.
- •Inability to give informed consent.
- •History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- •Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomy of the thyroid gland.
- •Documented coronary disease.
- •Advanced renal impairment (creatinine > 1,5mg/dl).
- •During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
- •Pregnancy, breastfeeding
研究组 & 干预措施
Indocyanine Green
Intravenous injection of 0.25 mg/kg Indocyanine Green in patients with peritoneal carcinomatosis from colorectal cancer before the surgery
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
fluorescence intensity of tumoral and healthy tissues after IV injection of ICG to patients with peritoneal carcinomatosis from colorectal origin.
时间窗: 1 week
次要结局
未报告次要终点