Photo-medicine-Guided Dual Approach for Reoperation of Sentinel Lymph Nodes in Locally Recurrent Breast Cancer Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: SEEYOUN LEE
- Phone Number: +82-31-920-1736
Study Locations
-
-
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Goyang-si, Korea, Republic of
- Recruiting
- National Cancer Center
-
Contact:
- SEEYOUN LEE
- Phone Number: +82-31-920-1736
- Email: seeyoun@ncc.re.kr
-
Contact:
- SEEYOUN LEE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identification Rate of Sentinel Lymph Nodes (SLNs)
Time Frame: Day of Surgery
|
Day of Surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Comparison of Identification Rates Based on Sentinel Lymph Node Localization Techniques
Time Frame: Day of Surgery
|
Day of Surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SEEYOUN LEE, National Cancer Center, Korea
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC-2310621-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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