Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Uptake of the dye by the tissue(i.e metastatic SLN)
研究概览
简要总结
Breast malignant tumors are a serious threat to women's health, and the current treatment for breast malignant tumors is still dominated by surgery, but the problems faced by patients after surgery such as edema and tumor recurrence are still relatively common, and the high recurrence rate and the occurrence of postoperative complications are closely related to the removal of metastatic lymph nodes during surgery. Therefore, accurate assessment of sentinel lymph node (SLN) metastases is essential to determine the extent of axillary lymph node dissection (ALND) and minimize complications. In this study, we developed a new technique that can rapidly distinguish between metastatic lymph nodes and normal sentinel lymph nodes (SLNs) in breast cancer patients. Briefly, fresh tissue is incubated with the probe and imaged immediately after intraoperative sentinel lymph node resection to identify the metastatic status of SLN. The accuracy of fluorescence imaging is confirmed by pathological diagnosis.
详细描述
Following patient enrollment, surgical interventions were performed in accordance with standardized clinical protocols. During the operative procedure, the excised sentinel lymph nodes (SLNs) underwent specialized incubation processing. The detailed experimental protocol was conducted as follows:
- Preparation of incubation solution The molecular probe was reconstituted in phosphate-buffered saline (PBS) to create incubation solutions with concentration gradients of 6.25, 12.5, 25, and 50 μg/mL. Solution preparation was performed at ambient temperature under light-protected conditions.
- Ex vivo SLN tissue incubation Freshly excised SLN specimens were fully immersed in the prepared solutions for designated durations (1, 3, 5, 7, or 10 minutes). Subsequent processing included a 5-minute wash cycle with PBST buffer (0.05% Tween 20 in PBS) followed by blot-drying using absorbent filter paper.
- NIR-II fluorescence imaging analysis Imaging acquisition was conducted using the Digital Precision Medicine (DPM) NIR-II system. Following initial system parameter calibration and spatial scaling, fluorescence signals were captured and quantitatively analyzed to determine SLN metastatic status through proprietary diagnostic algorithms.
- Histopathological validation Final diagnostic confirmation was obtained through comprehensive histopathological examination conducted by certified pathologists.
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
- 否
入选标准
- •Adult patients between 18-75 years of age
- •Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
- •Breast cancer patients who are scheduled to undergo sentinel lymph node biopsy or axillary lymph node dissection;
- •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
结局指标
主要结局
Uptake of the dye by the tissue(i.e metastatic SLN)
时间窗: 1 year
Ability of the imaging system to discern the uptake of the dye by the metastatic SLN . Detected with imaging probe.
False positive rates of the NIR-II probe (ICG-CK)
时间窗: 1 year
Microscopic examination and immunohistochemistry of tumor performed by a pathologist. This will allow investigators to compare pathology results with fluorescence images taken by imaging probe to calculate false positive (i.e., identification of non metastatic SLN) rates of ICG-CK.
次要结局
未报告次要终点