Surgical Outcome of Breast Conserving Surgery Using Indocyanine Green Fluorescence in Breast Cancer Patients After Preoperative Chemotherapy: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Margin-positive rate in final pathological report
研究概览
简要总结
Neoadjuvant chemotherapy for advanced breast cancer has led to an increased rate of breast-conserving surgery (BCS) in these patients. As the demand for preoperative localization methods grows among surgeons performing BCS, traditional localization techniques have shown limitations. For non-palpable breast lesions, preoperative localization has commonly been achieved using ultrasound-guided skin markings or needle localization. However, these methods present challenges, including difficulty in depth localization for patients with large breasts and limitations in real-time re-verification during surgery due to air artifacts after incision. Needle localization, although commonly used, is invasive and poses risks such as displacement or detachment of the needle.
Indocyanine green (ICG), a fluorescent dye that appears green to the naked eye and is detectable by near-infrared (NIR) cameras, has been widely and safely used in clinical practice via intravenous or subcutaneous administration. Recently, ICG combined with NIR imaging has been adopted for sentinel lymph node biopsy in breast cancer and melanoma surgeries and is increasingly used as a localization method for various tumors, replacing conventional techniques.
A preliminary study (IRB No. NCC2016-0071) conducted at the institution evaluated ICG injection and NIR fluorescence imaging for tumor localization in early breast cancer patients undergoing BCS. The study demonstrated the efficacy of ICG-based localization in reducing the rate of positive surgical margins.
The objective of this study is to evaluate the effectiveness of ICG-guided tumor localization with NIR fluorescence imaging in patients with advanced breast cancer treated with neoadjuvant chemotherapy. It is hypothesized that this technique will allow for more accurate tumor excision compared to conventional methods, ultimately improving surgical outcomes.
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
- 是
入选标准
- •The Patient with locally advanced breast cancer who is eligible for breast-conserving surgery after receiving neoadjuvant chemotherapy
- •Aged over 18 years old
- •ECOG performance status: 0 or 1
- •The patients with written informed consent
排除标准
- •The patient who requires total mastectomy after receiving neoadjuvant chemotherapy
- •The patient with no residual mass on ultrasonography or only with microcalcifications
- •Pregnant or lactating patient
- •The patient with a disability to understand and provide consent
- •The patient with severe allergic history to indocyanine green
- •Iodine-sensitive patient
研究组 & 干预措施
ICG-F
Localization of breast cancer using indocyanine green fluorescence (ICG-F)
干预措施: The margin-positive rate using the localization technique (Procedure)
结局指标
主要结局
Margin-positive rate in final pathological report
时间窗: 10~35 days after surgery (the date when the pathological reports are available)
Collection of data for margin-positive rate from final pathological report after surgery
次要结局
- Localization rate(The day of surgery)
- Centralization(10~35 days after surgery (the date when the pathological reports are available))
- Margin-positive rate in frozen section(The day of surgery)
- Additional resection rate(The day of surgery)
- Re-excision rate(10~35 days after surgery (the date when the pathological reports are available))
- Adverse event rate(10~35 days after surgery (the date of follow-up after surgery))
研究者
Seeyoun Lee
Doctor, M.D., head of center for breast cancer
National Cancer Center, Korea