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, 40 participants, Yunnan Cancer Hospital

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Registry	NCT07018505
Status	Not yet recruiting
Study type	Observational
Enrollment	40 (Estimated)
Sponsor	Yunnan Cancer Hospital (Other); collaborators: Xiang'an Hospital of Xiamen University
Conditions	Sentinel Lymph Node, Breast Cancers, Metastases, Margin Assessment
Interventions	SERS detection (Diagnostic test)
Dates	start 2025-06-15 (estimated), primary completion 2026-06-15 (estimated), completion 2026-07-01 (estimated), first posted 2025-06-12, last updated 2025-06-12
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Surface Enhanced Raman Spectroscopy (SERS) Detection		Diagnostic Test: 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.

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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: Female, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Yunnan Cancer Hospital	Kunming, Yunnan	China

+Publications

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