2024-513163-57-00招募中2 期
Permanence of Indocyanine Green in axillary lymph nodes three weeks after subdermal injection in patients with Breast Carcinoma and metastatic lymph nodes: The FLUO Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Frequency of patient with at least 3 fluorescent lymph nodes
研究概览
简要总结
Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery [Time Frame: up to 3 weeks]
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to beginning any protocol specific procedure during treatment and follow up, according to regulatory requirements.
- •Age equal to or higher than 18 years
- •Patients affeted by breast cancer with cyto-histological confirmation of lymph node metastases and eligible for quadrantectomy/mastectomy combined with radical axillary surgery.
排除标准
- •Allergy to iodium or Indocyanine Green
- •Presence of Thyroid disorders (hyperthyroidism, autoimmune thyroid adenomas)
- •Patients not eligible for radical axillary surgery
- •Patient in a state of pregnancy
- •Under the age of 18 years
- •Non-autonomous patient or in need of a legal representative
结局指标
主要结局
Frequency of patient with at least 3 fluorescent lymph nodes
Frequency of patient with at least 3 fluorescent lymph nodes
次要结局
- Absolute frequency of total number of fluorescent lymph nodes per patient
- Absolute frequency of lymph nodes in group A and in group B
- Frequency of lymph nodes with metastases resulting fluorescent
- Frequency of fluorescent and non-fluorescent lymph nodes between subgroups of patients with different demographic and clinical characteristics
研究者
Stefano Fracon
Scientific
Centro Di Riferimento Oncologico Di Aviano
研究点 (1)
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