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

National Cancer Center (NCC)

Status and phase

Enrolling

Phase 2

Conditions

Breast Cancer

ICG (indocyanine Green)

Reoperation

Sentinel Lymph Node Biopsy (SLNB)

Locally Recurrent Breast Cancer

Treatments

Procedure: Identification rate of sentinel lymph node

Study type

Interventional

Funder types

Other

Identifiers

NCT06780748

NCC-2310621-2

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.