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临床试验/NCT07018505
NCT07018505尚未招募不适用

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

Yunnan Cancer Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult patients between 18-75 years of age
  • 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

排除标准

  • 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

结局指标

主要结局

Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes

时间窗: 1 year

Raman intensity of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes after SERS detection.

次要结局

  • Expression of EpCAM in the breast cancer and metastatic lymph nodes(1 year)
  • The Diagnostic Efficiency of SERS detection(1 year)

研究者

发起方
Yunnan Cancer Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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