RecruitingNCT07154563

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


Sponsor

Yunnan Cancer Hospital

Enrollment

60 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new fluorescent imaging probe that helps surgeons see sentinel lymph nodes (the first nodes cancer might spread to) more clearly during breast cancer surgery. The probe uses near-infrared light to identify whether cancer has spread to lymph nodes in real time. **You may be eligible if...** - You are between 18 and 75 years old - You have a breast lump or mass that is expected to be removable by surgery - You are scheduled to undergo sentinel lymph node biopsy or axillary lymph node removal - You are otherwise a good candidate for surgery **You may NOT be eligible if...** - You are unable to participate in the consent process - You have a serious medical condition that prevents surgery (e.g., severe heart/lung disease or blood clotting problems) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTNIR-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

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NCT07154563


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