EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers

Not yet recruiting

• Conditions: Sentinel Lymph Node; Breast Cancers; Metastases; Margin Assessment

• Registration Number: NCT07018505
• Lead Sponsor: Yunnan Cancer Hospital

Brief Summary

For early breast cancer patients, breast-conserving surgery and sentinel lymph node biopsy have emerged as the cornerstone of precision oncology, harmonizing oncologic efficacy with the preservation of breast cosmetics and axillary function. However, conventional margin evaluation relies on subjective experience, leading to positive margin rates of 15%-50% Additionally, sentinel lymph node biopsy faces inherent technical limitations, including prolonged procedural time and significant false-negative rates in detecting micro-metastases. To overcome these challenges, the investigators will introduce a stable "sandwich" EpCAM-targeted surface-enhanced Raman spectroscopy (SERS) detection system to provide rapid evaluation of surgical margins and sentinel lymph node (SLN) metastasis status. In brief, a portion of resected tissue will be immediately homogenized by grinding, and the tissue homogenate will then be analyzed using this detection system to determine its histological characteristics. Pathological confirmation will further validate the method. This approach aims to improve the accuracy and efficiency of intraoperative assessment of breast-conserving surgical margins and SLN status, thereby effectively reducing local recurrence rates and complications.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Study Start: 2025-06-15
• Primary Completion: 2026-06-15
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Adult patients between 18-75 years of age
• Female
• Patients presenting with a breast cancer to be resectable on pre-operative assessment
• Good operative candidate
• Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria

• Patients unable to participate in the consent process
• Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
• Other conditions that the researcher considers inappropriate to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes	1 year	Raman intensity of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes after SERS detection.

Secondary Outcome Measures

Name	Time	Method
Expression of EpCAM in the breast cancer and metastatic lymph nodes	1 year	Raman intensity of the breast cancer tissues and metastatic lymph nodes with different EpCAM expression level after SERS detection.
The Diagnostic Efficiency of SERS detection	1 year	The Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC), sensitivity and specificity of SERS detection for breast cancers and metastatic lymph nodes.

Trial Locations

Locations (1)

Yunnan Cancer Hospital; 🇨🇳 Kunming, Yunnan, China