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

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.

NCT Number	NCT06713161
Lead Sponsor	Yunnan Cancer Hospital Collaborators: Xiang'an Hospital of Xiamen University
Conditions	Breast Cancer, Sentinel Lymph Node, Metastases, Margin Assessment
Enrollment	40 participants
Start Date	2024-09-01
Primary Completion	2025-08-25 (estimated)
Study Completion	2025-12-25 (estimated)
Updated on ClinicalTrials.gov	2024-12-03