RecruitingNCT07154563

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


Sponsor

Yunnan Cancer Hospital

Enrollment

60 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria2

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

Interventions

DIAGNOSTIC_TESTNIR-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.


Locations(1)

Yunnan Cancer Hospital, Kunming, Yunnan 650118

Kunming, Yunnan, China

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NCT07154563


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