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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-12-01

Brief Summary

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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.

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Detailed Description

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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:

1. Preparation of incubation solution The molecular probe was reconstituted in phosphate-buffered saline (PBS) to create incubation solutions with concentration gradients of 6.25, 12.5, 25, and 50 μg/mL. Solution preparation was performed at ambient temperature under light-protected conditions.
2. Ex vivo SLN tissue incubation Freshly excised SLN specimens were fully immersed in the prepared solutions for designated durations (1, 3, 5, 7, or 10 minutes). Subsequent processing included a 5-minute wash cycle with PBST buffer (0.05% Tween 20 in PBS) followed by blot-drying using absorbent filter paper.
3. NIR-II fluorescence imaging analysis Imaging acquisition was conducted using the Digital Precision Medicine (DPM) NIR-II system. Following initial system parameter calibration and spatial scaling, fluorescence signals were captured and quantitatively analyzed to determine SLN metastatic status through proprietary diagnostic algorithms.
4. Histopathological validation Final diagnostic confirmation was obtained through comprehensive histopathological examination conducted by certified pathologists.

Conditions

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Breast Cancer Metastatic Sentinel Lymph Node Sentinel Lymph Node Biopsy (SLNB) Metastasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NIR-II probe incubation

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.

NIR-II probe (i.e ICG-CK) incubation solution

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No