A Feasibility Study (ROLL-I) of Indocyanine Green (ICG) Fluorescence Mapping for Non-palpable Breast Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- difference between the area of the indocyanine green fluorescence and radioactive area
研究概览
简要总结
Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among women. The incidence of non-palpable tumors is estimated at 60%. Their better prognosis and their small size encourage the investigators for finding methods simpler and more efficient to treat them by breast-conserving surgery with acceptable cosmetic results.
The pre-operative detection of the tumor lesion is currently carried out by two methods: the radioactive seed localization and guidewire technique. Each has its disadvantages: the guidewire is uncomfortable for the patients (pain, hematomes..), whereas the radiocolloid requires a specialized and complex organization around this radioactive product.
Recently, a novel method of using indocyanine green (ICG) fluorescence has been described in breast cancer and seems promising.
In this study, investigators evaluate the feasibility and performance of indocyanine green fluorescence in non-palpable tumor detection in comparison with radioactive seed localization (ROLL)
Secondary objectives are evaluate the feasibility of the location by the radiologist, feasibility of detection by the surgeon, study of the product and the probe.
详细描述
The study is prospectively conducted during six months of 2017-2018 in the department of gynaecology of Montpellier .
This study includes ten women. Patients will receive both techniques: indocyanine green fluorescence (experimental technique) and radiocolloid (reference technique).
Inclusion will be during the preoperative consultation after checking the inclusion / non inclusion criteria and signing a written consent.
Radioactive localization with technetium will be done on surgery eve like usual. Fluorescence localization with ICG will be done in the operating room under general anesthesia by the radiologist under ultrasound.
By a probe (Euromedical instruments), surgeon identified and marked the site of the skin by observing the area of the ICG fluorescence. Then, in the same way, the surgeon marked the tumor by the radioactive probe detecting the radioactive signal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman Age ≥ 18 years
- •Non-palpable tumor
- •Single tumor
- •First breast surgery
- •Histology: ductal carcinoma
- •Written consent
- •Being affiliated or benefiting from a French social security system
排除标准
- •palpable tumor
- •multifocal tumor
- •antecedent of breast surgery
结局指标
主要结局
difference between the area of the indocyanine green fluorescence and radioactive area
时间窗: during breast surgery
By a probe (Euromedical instruments), surgeon identified and marked the site of the skin by observing the area of the ICG fluorescence. Then, in the same way, the surgeon marked the tumor by the radioactive probe detecting the radioactive signal. An picture will be made of these two markers and it will be noted the distance between them. At the end of the surgical procedure, surgeon identified and marked in the excised sample the area of fluorescence and radioactive. The pathological examination of the resected specimen will describe positions of mark compared tumor.
次要结局
未报告次要终点