RecruitingPhase 2NCT06780748

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


Sponsor

National Cancer Center, Korea

Enrollment

30 participants

Start Date

Aug 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 1.
  • Patients who voluntarily decide to participate in the study and provide written informed consent.

Exclusion Criteria4

  • 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.

Interventions

PROCEDUREIdentification rate of sentinel lymph node

To evaluate the identification rate of sentinel lymph nodes (SLNs). The study will compare the identification rates based on different localization techniques for SLN mapping


Locations(1)

National Cancer Center

Goyang-si, South Korea

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NCT06780748


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