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

Recruiting now

Conditions studied: Breast Cancer Metastatic, Sentinel Lymph Node, Sentinel Lymph Node Biopsy (SLNB), Metastasis

In brief

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 facts

Study ID

NCT07154563

Run by

Yunnan Cancer Hospital

People needed

60

Starts

2025-02-01

Expected to finish

2026-12-01

Last updated by the study team

2025-09-04

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients unable to participate in the consent process
• Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc

Where it is running

• Yunnan Cancer Hospital, Kunming, Yunnan 650118 — Kunming, Yunnan, China (enrolling)

Full record on ClinicalTrials.gov

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