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

NCT07154563 | Recruiting DMC

• 1 other identifier: KYLX2025-060
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

NIR-II; Breast Cancer; Sentinel Lymph Node; Metastasis

Outcome Measures

Primary Outcomes (2)

• Uptake of the dye by the tissue(i.e metastatic SLN)

  Ability of the imaging system to discern the uptake of the dye by the metastatic SLN . Detected with imaging probe.

  1 year

• False positive rates of the NIR-II probe (ICG-CK)

  Microscopic examination and immunohistochemistry of tumor performed by a pathologist. This will allow investigators to compare pathology results with fluorescence images taken by imaging probe to calculate false positive (i.e., identification of non metastatic SLN) rates of ICG-CK.

  1 year

Study Arms (1)

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.

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

Interventions

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

NIR-II probe incubation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators plan to enroll 90 female patients, aged 18 to 75 years, who have been assessed to have resectable breast nodules or masses and are scheduled to undergo surgery. During the surgery, the resected lymph nodes will be incubated with theNIR-II probe(ICG-CK) solution, and NIR-II fluorescence signals from the tissues will be collected.

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

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead
• Xiang'an Hospital of Xiamen University: collaborator

Study Sites (1)

Yunnan Cancer Hospital, Kunming, Yunnan 650118

Kunming, Yunnan, China

RECRUITING

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Neoplasm Metastasis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Junhong Chen, Postgraduate

CONTACT

86+17782287838; 1145644908@qq.com

Weiling Chen, Doctor

CONTACT

86+13646039812; 913208146@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)