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Clinical Trials in South Korea / NCT06780748
Recruiting Phase 2

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

NCT06780748 · tracked via the Priya Life Science South Korea tracker
Sponsor
National Cancer Center, Korea
Phase
Phase 2
Started
2023-08-13
Last updated
2025-01-17

Condition(s) studied

Breast CancerLocally Recurrent Breast CancerSentinel Lymph Node Biopsy (SLNB)ReoperationICG (indocyanine Green)

Investigational drug(s) / intervention(s)

Identification rate of sentinel lymph node

Identification 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

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Cancer Center Goyang-si South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06780748 on ClinicalTrials.gov ↗ ← All trials in South Korea