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

NCT07018505 | Not Yet Recruiting DMC

• 1 other identifier: KYLX2025-149
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sentinel Lymph Node; Breast Cancers; Metastases; Margin Assessment

Keywords

Sentinel Lymph Node; Surface Enhanced Raman Spectroscopy; EpCAM; Breast cancers; Surgical margin

Outcome Measures

Primary Outcomes (1)

• Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes

  Raman intensity of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes after SERS detection.

  1 year

Secondary Outcomes (2)

• Expression of EpCAM in the breast cancer and metastatic lymph nodes

  1 year

• The Diagnostic Efficiency of SERS detection

  1 year

Study Arms (1)

Surface Enhanced Raman Spectroscopy (SERS) Detection

Intraoperatively, approximately 5 mm samples of tumor and adjacent normal tissues are collected from breast cancer patients after resection. After lymph nodes dissection, the tissues are bisected longitudinally along the maximum cross-section. The collected tissues are then divided into two portions. One portion is weighed, and tissue lysis buffer (RIPA:PIC:PMSF = 100:1:1) is added at a ratio of 5 μL per 1 mg tissue. The tissue is minced into 1 mm fragments on ice, and 3 mm zirconium beads are added for homogenization based on tissue weight. The homogenate is centrifuged at 12,000 g for 2 min at 4°C. The supernatant (50 μL) is collected for detection, and the remaining tissue is reserved for pathological evaluation.

Diagnostic Test: SERS detection

Interventions

SERS detection DIAGNOSTIC_TEST

Incubation: A mixture of 20 μL (0.5 mg/mL) magnetic beads (MB@RB20115UD), 40 μL SERS nanotags (Au-IR808@RB20115UC), and prepared sample is incubated for 5 min. Washing: The supernatant is removed after magnetic separation (30 s), followed by washing with PBST (pH 7.4, 0.05% Tween-20). Detection: The separated pellet is resuspended in 10 μL ultrapure water. Then 2 μL solution is spotted onto a 2.5 mm × 2.5 mm gold substrate for air-drying. Raman spectra are acquired using a portable spectrometer (785 nm laser, 500 mW power, 5 s acquisition time, triplicate measurements). Peak areas within 540-570 cm-1 are quantified.

Surface Enhanced Raman Spectroscopy (SERS) Detection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable breast cancer and are scheduled to undergo surgery. During the surgery, the resected cancers and lymph nodes will be collected for SERS detection, and Raman signals from the tissues will be collected.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead
• Xiang'an Hospital of Xiamen University: collaborator

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location

Related Publications (1)

• Guan PC, Zhang H, Li ZY, Xu SS, Sun M, Tian XM, Ma Z, Lin JS, Gu MM, Wen H, Zhang FL, Zhang YJ, Yu GJ, Yang C, Wang ZX, Song Y, Li JF. Rapid Point-of-Care Assay by SERS Detection of SARS-CoV-2 Virus and Its Variants. Anal Chem. 2022 Dec 27;94(51):17795-17802. doi: 10.1021/acs.analchem.2c03437. Epub 2022 Dec 13.

  PMID: 36511436 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Central Study Contacts

Kang-Liang Lou, Doctor

CONTACT

+8615158661275; 15158661275@163.com

Jing-Wen Bai, Doctor

CONTACT

baijingwen666@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: June 15, 2025
• Primary Completion: June 15, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)