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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorYunnan Cancer Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Patients unable to participate in the consent process

Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yunnan Cancer Hospital

Lead sponsor

Xiang'an Hospital of Xiamen University

Collaborator