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临床试验/NCT06780748
NCT06780748招募中2 期

Photo-medicine-Guided Dual Approach for Reoperation of Sentinel Lymph Nodes in Locally Recurrent Breast Cancer Patients

National Cancer Center, Korea1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月13日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
30
试验地点
1
主要终点
Identification Rate of Sentinel Lymph Nodes (SLNs)

研究概览

简要总结

Sentinel lymph node biopsy (SLNB) is essential for staging and treatment planning in early breast cancer patients. As a less invasive procedure, it has replaced axillary lymph node dissection (ALND) by reducing complications and improving patient outcomes. However, the 10-year local recurrence rate for breast cancer is approximately 2-10%, and the role of SLNB in the surgical management of recurrent breast cancer remains unclear.

According to the NCCN guidelines and Korean Breast Cancer Treatment Recommendations, surgical management for recurrent breast cancer includes mastectomy and axillary lymph node surgery for patients who have previously undergone breast-conserving surgery and radiotherapy. For axillary recurrence, surgery is recommended if feasible, followed by radiotherapy. Conversely, the ASCO guidelines recommend SLNB for surgically resectable recurrent breast cancer, and recent studies have reported promising outcomes for repeat sentinel lymph node biopsy (reSLNB). Vugts G et al. demonstrated an 80.1% tumor-negative rate with reSLNB, suggesting that ALND could be avoided in many cases.

Although reSLNB offers the advantage of reducing unnecessary invasive procedures and associated complications, challenges remain due to disrupted lymphatic pathways in patients who have previously undergone surgery and radiotherapy. Additionally, research on the long-term prognosis of these patients is still limited.

This study aims to evaluate the detection rate of sentinel lymph nodes using a photo-medicine-based dual localization technique that combines traditional radiotracer methods with indocyanine green-fluorescence (ICG-F) in patients undergoing reSLNB for locally recurrent breast cancer.

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

  • •Patients with ipsilateral locally recurrent breast cancer who previously underwent ipsilateral axillary surgery.
  • •Female patients aged 18 years or older.
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
  • •Patients who voluntarily decide to participate in the study and provide written informed consent.

排除标准

  • •Patients with distant metastases.
  • •Patients who previously underwent ipsilateral mastectomy.
  • •Pregnant or breastfeeding women.
  • •Patients with a general condition that impairs the ability to understand or provide informed consent.

研究组 & 干预措施

Radioactive Isotope (RI) with Indocyanine Green Fluorescence (ICG-F)

Experimental

Sentinel lymph node mapping using a combination of radioactive isotope and indocyanine green fluorescence (ICG-F)

干预措施: Identification rate of sentinel lymph node (Procedure)

结局指标

主要结局

Identification Rate of Sentinel Lymph Nodes (SLNs)

时间窗: Day of Surgery

次要结局

  • Comparison of Identification Rates Based on Sentinel Lymph Node Localization Techniques(Day of Surgery)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Seeyoun Lee

Doctor, M.D., head of center for breast cancer

National Cancer Center, Korea

研究点 (1)

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