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

NCT06780748 | Recruiting Phase 2 DMC

• 1 other identifier: NCC-2310621-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Keywords

Breast cancer; Locally Recurrent Breast cancer; Sentinel Lymph Node Biopsy (SLNB); Reoperation; ICG(indocyanine green)

Outcome Measures

Primary Outcomes (1)

• Identification Rate of Sentinel Lymph Nodes (SLNs)

  Day of Surgery

Secondary Outcomes (1)

• Comparison of Identification Rates Based on Sentinel Lymph Node Localization Techniques

  Day of Surgery

Study Arms (1)

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

EXPERIMENTAL

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

Procedure: Identification rate of sentinel lymph node

Interventions

Identification rate of sentinel lymph node 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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• SEEYOUN LEE

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEEYOUN LEE

CONTACT

+82-31-920-1736

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, M.D., head of center for breast cancer

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: August 13, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

KR (1)