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.
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
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
The investigators plan to enroll 40 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 tumors and lymph nodes will be incubated with theNIR-II probe(ICG-POL6326) solution, and NIR-II fluorescence signals from the tissues will be collected.
Case-only
Prospective
NIR-II Probe(i.e ICG-POL6326) incubation solution
Diagnostic testAfter 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.
Expression of the CXCR4 in the tumor
Ability of the imaging system to detect the expression of the CXCR4 in the mass (i.e tumor).
Uptake of the dye by the tissue(i.e tumor,metastatic SLN)
Ability of the imaging system to discern the uptake of the dye by the tumor or metastatic SLN . Detected with imaging probe.
False positive rates of the NIR-II probe (ICG-POL6326)
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 CXCR4-positive tumors) rates of ICG-POL6326.
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Yunnan Cancer Hospital
Lead sponsor
Xiang'an Hospital of Xiamen University
Collaborator
