Study of the (Intravenously Injected) Indocyanine Green Distribution in the Margins of Breast Cancer After Tumorectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- - Evaluation of the ability of NIR imaging to show (fluorescent) the tumoral volumes, the tumoral tissues to be analyzed by the pathologist, especially at the level of the operative margins
研究概览
简要总结
We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent
详细描述
In the operating room:
ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.
The surgeon will remove the tumour (and the axillary lymph nodes) as usual.
Optionally, peroperative "in vivo" imaging of the dissection of the tumour using the PDE camera will be performed.
In the Laboratory of Pathology:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection,
- •Informed consent form signed.
排除标准
- •Diagnosis of mammary cancer established by "gross" biopsy,
- •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
study of the correlation between fluorescence and margins of the tumours after iv injection of Indocyanine Green
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
- Evaluation of the ability of NIR imaging to show (fluorescent) the tumoral volumes, the tumoral tissues to be analyzed by the pathologist, especially at the level of the operative margins
时间窗: 17 months
次要结局
- - Analysis of the correlation between (levels of) ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist(17 months)