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

NCT ID: NCT06780748

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-13
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Identification rate of sentinel lymph node

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Seeyoun Lee

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEEYOUN LEE

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center

Goyang-si, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

SEEYOUN LEE

Role: CONTACT

+82-31-920-1736

Facility Contacts

SEEYOUN LEE

Role: primary

seeyoun@ncc.re.kr

+82-31-920-1736

SEEYOUN LEE

Role: backup

Other Identifiers

NCC-2310621-2

Identifier Type: -

Identifier Source: org_study_id