Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status
Recruiting · NCT06713161 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Yunnan Cancer Hospital - Kunming, Yunnan, China