NCT02817334Unknown2 期
A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- detection rate
研究概览
简要总结
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.
In this study, our hypothesis are as following:
- As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
- indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
详细描述
Indocyanine green, ICG (ICG-fluorescence)
- ICG is the most commonly used fluorophore which approve by FDA.
- NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
- Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.
Nonpalpable benign brest lesion localization
- New method for the localization and resection of non-palpable breast lesions.
- The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •nonpalpable breast tumor < 5cm in patients with breast cancer.
- •consented patients with more than 18 years
- •Eastern Cooperative Oncology Group Performance status 0 or 1
- •patients who need breast biopsy as treatment for breast cancer.
排除标准
- •nonpalpable breast tumor ≥ 5cm in patients with breast cancer.
- •inflammatory cancer of breast or patients who need MRM
- •pregnancy
- •history of severe allergy to ICG(Indocyanine Green)
- •iode hypersensitiveness
研究组 & 干预措施
indocyanine green
Experimental
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Intervention: Drug: indocyanine green
干预措施: indocyanine green (Drug)
结局指标
主要结局
detection rate
时间窗: one day
after complete resection with intraoperative ultrasound confirmed the lesion
次要结局
- determine the pathological stability(one day)
研究者
So-Youn Jung
Medical Doctor
National Cancer Center, Korea
研究点 (1)
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