Breast Cancers, Margin Assessment, Metastases, Sentinel Lymph Node
Conditions
Keywords
Sentinel Lymph Node, Surface Enhanced Raman Spectroscopy, EpCAM, Breast cancers, Surgical margin
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.
Interventions
DIAGNOSTIC_TESTSERS 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.
Sponsors
Xiang'an Hospital of Xiamen University
Yunnan Cancer Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactKang-Liang Lou, Doctor
Backup ContactJing-Wen Bai, Doctor
Outcome results
None listed