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Not yet recruiting NCT07018505

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

— Observational Sentinel Lymph Node Breast Cancers Metastases Margin Assessment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SERS detection.
Who it may be relevant to
Registry conditions: Sentinel Lymph Node, Breast Cancers, Metastases, Margin Assessment. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 spectromete

Primary outcome measures

  • Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes [Time frame: 1 year]
Secondary outcome measures (2)
  • Expression of EpCAM in the breast cancer and metastatic lymph nodes [Time frame: 1 year]
  • The Diagnostic Efficiency of SERS detection [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Yunnan Cancer Hospital — Kunming

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

Identifiers

NCT: NCT07018505 · KYLX2025-149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗