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

June 4, 2025 updated by: Yunnan Cancer Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yunnan Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guo-Jun Zhang, Doctor
        • Principal Investigator:
          • Kang-Liang Lou, Doctor
        • Principal Investigator:
          • Jing-Wen Bai, Doctor
        • Sub-Investigator:
          • Lei Niu, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes
Time Frame: 1 year
Raman intensity of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes after SERS detection.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of EpCAM in the breast cancer and metastatic lymph nodes
Time Frame: 1 year
Raman intensity of the breast cancer tissues and metastatic lymph nodes with different EpCAM expression level after SERS detection.
1 year
The Diagnostic Efficiency of SERS detection
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunnan Cancer Hospital

Collaborators

Xiang'an Hospital of Xiamen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 4, 2025

First Submitted That Met QC Criteria

June 4, 2025

First Posted (Actual)

June 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLX2025-149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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