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NCT Number: NCT07018505

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

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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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location contact

Guo-Jun Zhang, Doctor

CONTACT

[email protected]

+86 0871-68231187

Guo-Jun Zhang, Doctor

PRINCIPAL_INVESTIGATOR

Jing-Wen Bai, Doctor

PRINCIPAL_INVESTIGATOR

Kang-Liang Lou, Doctor

CONTACT

[email protected]

8615158661275

Kang-Liang Lou, Doctor

PRINCIPAL_INVESTIGATOR

Lei Niu, Master

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing-Wen Bai, Doctor

CONTACT

[email protected]

Kang-Liang Lou, Doctor

CONTACT

[email protected]

+8615158661275

Sponsors and collaborators

Lead sponsor

Yunnan Cancer Hospital

Other

Collaborators

  • Xiang'an Hospital of Xiamen University

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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