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.
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
Patients unable to participate in the consent process
Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
The investigators plan to enroll 90 female patients, aged 18 to 75 years, who have been assessed to have resectable breast nodules or masses and are scheduled to undergo surgery. During the surgery, the resected lymph nodes will be incubated with theNIR-II probe(ICG-CK) solution, and NIR-II fluorescence signals from the tissues will be collected.
Case-only
Prospective
NIR-II probe (i.e ICG-CK) incubation solution
Diagnostic testAfter incubating the lymph node tissue with an optimal concentration of NIR-II probe for an appropriate amount of time, the tissue is washed with eluent, and then the fluorescence intensity of different tissues is detected to assess whether the tissue has cancer tissue invasion.
Uptake of the dye by the tissue(i.e metastatic SLN)
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)
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.
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Yunnan Cancer Hospital
Lead sponsor
Xiang'an Hospital of Xiamen University
Collaborator
