NCT06713161 Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status
| NCT ID | NCT06713161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yunnan Cancer Hospital |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2025-08-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-09-01 with a primary completion date of 2025-08-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06713161 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06713161 currently recruiting?
Yes, NCT06713161 is actively recruiting participants. Contact the research team at 18059766094@163.com for enrollment information.
Where is the NCT06713161 trial being conducted?
This trial is being conducted at Kunming, China.
Who is sponsoring the NCT06713161 clinical trial?
NCT06713161 is sponsored by Yunnan Cancer Hospital. The trial plans to enroll 40 participants.
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