NCT07154563 Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Cancer
| NCT ID | NCT07154563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yunnan Cancer Hospital |
| Condition | Breast Cancer Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-12-01 |
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 60 participants in total. It began in 2025-02-01 with a primary completion date of 2026-12-01.
⚠ 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
Breast malignant tumors are a serious threat to women's health, and the current treatment for breast malignant tumors is still dominated by surgery, but the problems faced by patients after surgery such as edema and tumor recurrence are still relatively common, and the high recurrence rate and the occurrence of postoperative complications are closely related to the removal of metastatic lymph nodes during surgery. Therefore, accurate assessment of sentinel lymph node (SLN) metastases is essential to determine the extent of axillary lymph node dissection (ALND) and minimize complications. In this study, we developed a new technique that can rapidly distinguish between metastatic lymph nodes and normal sentinel lymph nodes (SLNs) in breast cancer patients. Briefly, fresh tissue is incubated with the probe and imaged immediately after intraoperative sentinel lymph node resection to identify the metastatic status of SLN. The accuracy of fluorescence imaging is confirmed by pathological diagnosis.
Eligibility Criteria
Inclusion Criteria: * Adult patients between 18-75 years of age * Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment * Breast cancer patients who are scheduled to undergo sentinel lymph node biopsy or axillary lymph node dissection; * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07154563 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07154563 currently recruiting?
Yes, NCT07154563 is actively recruiting participants. Contact the research team at 1145644908@qq.com for enrollment information.
Where is the NCT07154563 trial being conducted?
This trial is being conducted at Kunming, China.
Who is sponsoring the NCT07154563 clinical trial?
NCT07154563 is sponsored by Yunnan Cancer Hospital. The trial plans to enroll 60 participants.
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