Near-infrared Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After Intravenous Injection of Indocyanine Green (a Feasibility Study)
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection
研究概览
简要总结
The purpose of this study is to determine if NIR fluorescent imaging is an effective approach to detect the margins of head and neck tumours or lymph nodes draining the tumour
详细描述
Primary objective:
definition of the distribution of intravenously injected ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients or in nodes recurrences in head and neck cancer
Secondary objectives:
- Evaluation of the ability of NIR fluorescence imaging to determine the tumoral volume, specifically the margins of the tumoral tissues (in the operating room and in the pathology department)
- Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes
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
- •All patients requiring neck dissection with or without resection of the primary (the decision and the type of neck dissection are preliminary decided during head and neck multidisciplinary oncologic consultation).
- •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 autonomies 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
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection
时间窗: 7 months
After IV injection of Indocyanine Green just before the surgery to head and neck cancer patients, we will study the fluorescence due to ICG in cervical lymph nodes and in the primary lesion.
次要结局
未报告次要终点