About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SERS detection
Treatment groups
Sponsors and collaborators
Yunnan Cancer Hospital
Lead sponsor
Xiang'an Hospital of Xiamen University
Collaborator