An observational study in Breast Cancer Metastatic, Sentinel Lymph Node and Sentinel Lymph Node Biopsy (SLNB), sponsored by Yunnan Cancer Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Yunnan Cancer Hospital · Observational
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.
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:
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 60 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.
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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.
Exclusion Criteria:
NIR-II probe incubation Group/Cohort Description: Freshly excised SLNs will be fully immersed in NIR-II probe ((i.e:ICG-CK) incubation solution (6.25, 12.5, 25, 50, 100 ug/mL) for 1, 3, 5, 7, or 10 min, then rinsed with PBST buffer for 5 min and dried with absorbent paper. NIR-II fluorescence imaging will then be performed under the DPM NIR-II system. The correlation between pathological features and fluorescence information will be further analyzed.
Diagnostic Test: NIR-II probe (i.e ICG-CK) incubation solution
After 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.
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: No
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Yunnan Cancer Hospital