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RECRUITING
NCT07154563

Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Cancer

Sponsor: Yunnan Cancer Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2025-02-01

Completion Date

2026-12-01

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

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.

Locations (1)

Yunnan Cancer Hospital, Kunming, Yunnan 650118

Kunming, Yunnan, China