Clinical trial NCT07018505: EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers
Official title: EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sentinel Lymph Node
Breast Cancers
Metastases
Margin Assessment
Keywords: Sentinel Lymph Node
Surface Enhanced Raman Spectroscopy
EpCAM
Breast cancers
Surgical margin
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Xiang'an Hospital of Xiamen University
First posted: 2025-06-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable breast cancer and are scheduled to undergo surgery. During the surgery, the resected cancers and lymph nodes will be collected for SERS detection, and Raman signals from the tissues will be collected.

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.


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

Primary outcomes:
measure: Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes
timeFrame: 1 year
Secondary outcomes:
measure: Expression of EpCAM in the breast cancer and metastatic lymph nodes
timeFrame: 1 year
measure: The Diagnostic Efficiency of SERS detection
timeFrame: 1 year
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
References:
citation: 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.