Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.
研究概览
简要总结
The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.
详细描述
Primary objective:
Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent).
Secondary objectives:
Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.
Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned.
- •Informed Consent signed.
排除标准
- •Diagnosis of breast cancer established by lumpectomy or "macro-biopsy".
- •Operation after neo-adjuvant chemotherapy,
- •Age less than 18 years.
- •For pre-menopausal women, an operation planned for the second phase of their cycle.
- •Inability to give informed consent.
- •History of allergy or hypersensitivity to the investigational product, iodine.
- •Clinical or biological hyperthyroidism.
- •Known "toxic" thyroid nodules or known autonomous (hyperfunctional) thyroid.
- •A reported pathological coronary artery disease.
- •Creatinine > 1.5 mg / dl.
- •During the 2 weeks before surgery, being on medications which are known to interfere with the ICG (ie anticonvulsants, heparin and haloperidol).
- •Pregnancy or breast feeding period.
研究组 & 干预措施
indocyanine green
Indocyanine green is injected intravenously.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.
时间窗: 10 months
Detecting of the fluorescence in between benign and malignant tissue by near infra-red imaging with a camera dictated to identify the margin of the tumor, and Histological detection of indocyanine green distribution in tumor bearing breasts and in axillary pieces of dissection and the detection of tumor cells in lymphe nodes.
次要结局
- Microscopical detection of indocyanine green in breast tissue.(10 months.)