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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorYunnan Cancer Hospital

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

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yunnan Cancer Hospital

Lead sponsor

Xiang'an Hospital of Xiamen University

Collaborator