Fast detection of cancer in sentinel lymph nodes using a new NIR-II fluorescent probe.
Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Cancer
This test applies a new near-infrared (NIR-II) fluorescent probe to freshly removed sentinel lymph nodes to quickly tell adults with breast cancer whether the cancer has spread there.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Yunnan Cancer Hospital Academic / other |
| Locations | 1 site (Kunming, Yunnan) |
| Trial ID | NCT07154563 on ClinicalTrials.gov |
What this trial studies
This observational protocol uses an ex vivo approach in which freshly excised sentinel lymph nodes are incubated briefly in graded concentrations of a pan-cytokeratin-targeting NIR-II probe and then imaged with a dedicated NIR-II system. Imaging data are processed with quantitative algorithms to generate fluorescence-based predictions of metastatic involvement. Multiple incubation times and probe concentrations are explored to optimize signal and speed. Final diagnoses are confirmed by standard histopathology to compare accuracy and concordance with the fluorescence readout.
Who should consider this trial
Good fit: Adults aged 18–75 with resectable breast cancer who are scheduled for sentinel lymph node biopsy or axillary lymph node dissection and who can give informed consent.
Not a fit: Patients who are not undergoing SLN removal, who have contraindications to surgery, or who cannot provide informed consent are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, surgeons could learn sentinel node status during the operation, potentially avoiding unnecessary axillary dissections and reducing postoperative complications.
How similar studies have performed: Near-infrared I (ICG) imaging is widely used for node mapping and NIR-II probes have shown promising preclinical results, but clinical validation for rapid ex vivo SLN metastasis detection is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kunming, Yunnan
- Yunnan Cancer Hospital, Kunming, Yunnan 650118 — Kunming, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Junhong Chen, Postgraduate
- Email: 1145644908@qq.com
- Phone: 86+17782287838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.