RecruitingNCT06713161

Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status

Sponsor

Yunnan Cancer Hospital

Enrollment

40 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Sentinel Lymph Node Metastases Margin Assessment

Summary

Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Near-infrared-II (NIR-II) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. Here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(SLN). In brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of SLN. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

Adult patients between 18-75 years of age
Female
Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
Good operative candidate
Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria3

Patients unable to participate in the consent process
Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
Other conditions that the researcher considers inappropriate to participate in the study

Interventions

DIAGNOSTIC_TESTNIR-II Probe(i.e ICG-POL6326) incubation solution

After the tissues were incubated with the optimal concentration of the NIR-II probe for the appropriate time, the tissues were washed with the eluate, and then the fluorescence intensity of different tissues was detected to evaluate whether the tissues had cancer tissue invasion.