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

Phase 2

Recruiting

• Conditions: Breast Cancer; Locally Recurrent Breast Cancer; Sentinel Lymph Node Biopsy (SLNB); Reoperation; ICG (indocyanine Green)

• Registration Number: NCT06780748
• Lead Sponsor: National Cancer Center, Korea

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-13
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Identification Rate of Sentinel Lymph Nodes (SLNs)	Day of Surgery

Secondary Outcome Measures

Name	Time	Method
Comparison of Identification Rates Based on Sentinel Lymph Node Localization Techniques	Day of Surgery

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Korea, Republic of