NCT02172989已完成不适用
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- non-palpable lesion localization 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
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.
- •patients who need breast biopsy as treatment for breast cancer.
- •Eastern Cooperative Oncology Group Performance status 0 or 1
- •consented patients with more than 20 years, less than 70 years
排除标准
- •nonpalpable benign breast lesion ≥ 2cm in patients with breast cancer.
- •pregnancy
- •history of severe allergy to ICG(Indocyanine Green)
- •iode hypersensitiveness
结局指标
主要结局
non-palpable lesion localization rate
时间窗: up to 6month
non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients
次要结局
- lesion of resection size, completeness of resection(up to 6month)
研究者
So-Youn Jung
Medical Dotor
National Cancer Center, Korea
研究点 (1)
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