Clinical trial · Observational
Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Metastatic | — | UNRESOLVED | — |
| Metastasis | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NIR-II probe (i.e ICG-CK) incubation solution | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NIR-II probe incubation
- description
- 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.
- interventionNames
- Diagnostic Test: NIR-II probe (i.e ICG-CK) incubation solution
Primary outcomes (2)
- measure
- Uptake of the dye by the tissue(i.e metastatic SLN)
- timeFrame
- 1 year
- description
- Ability of the imaging system to discern the uptake of the dye by the metastatic SLN . Detected with imaging probe.
- measure
- False positive rates of the NIR-II probe (ICG-CK)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available