Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NIR-II probe (i.e ICG-CK) incubation solution.
- Who it may be relevant to
- Registry conditions: Breast Cancer Metastatic, Sentinel Lymph Node, Sentinel Lymph Node Biopsy (SLNB), Metastasis. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Uptake of the dye by the tissue(i.e metastatic SLN) [Time frame: 1 year]
- False positive rates of the NIR-II probe (ICG-CK) [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Yunnan Cancer Hospital, Kunming, Yunnan 650118 — Kunming
Identifiers
NCT: NCT07154563 · KYLX2025-060