Humanized ferritin near‑infrared fluorescent probe to find sentinel lymph node metastases in early gastric cancer
A Humanized Ferritin-Based NIR Fluorescent Probe for Discrimination Between Benign and Malignant Sentinel Lymph Nodes in Early Gastric Cancer
This project will test a humanized ferritin near‑infrared dye injected during surgery to help surgeons see whether early gastric cancer has spread to sentinel lymph nodes in adults having tumor removal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 47 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07294638 on ClinicalTrials.gov |
What this trial studies
This observational protocol uses a humanized ferritin‑based NIR fluorescent probe (VE/CX‑FTn‑ICG) injected intraoperatively to map sentinel lymph nodes (SLNs) in patients with early gastric adenocarcinoma. Surgeons will use near‑infrared imaging to identify fluorescent SLNs and those nodes will be compared with standard pathological examination to determine metastatic status. The approach aims to distinguish benign from malignant SLNs in real time to inform the extent of lymph node dissection. The work is being conducted at a single center, Nanfang Hospital, Southern Medical University in Guangzhou, China, in adults eligible for radical resection (cT1–cT2, tumor ≤4 cm).
Who should consider this trial
Good fit: Adults (≥18 years) with pathologically confirmed early gastric adenocarcinoma (cT1–cT2) with tumor diameter ≤4 cm who are scheduled for radical resection and who provide informed consent.
Not a fit: Patients with more advanced tumors (beyond cT2 or >4 cm), those not undergoing surgical resection, or those with contraindications to the injection or imaging procedure are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the probe could let surgeons avoid unnecessary extensive lymph node dissection and reduce operative morbidity while preserving oncologic safety.
How similar studies have performed: Fluorescent tracers such as ICG have shown feasibility for SLN mapping in gastric cancer, but humanized ferritin‑based NIR probes represent a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically or cytologically confirmed early gastric cancer eligible for radical resection, with histologically verified adenocarcinoma component (cT1-cT2, tumor diameter ≤4 cm);Age≥18years；No gender restriction；voluntary participation with written informed consent. Exclusion Criteria: * Patients deemed ineligible for participation by the investigator's assessment.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University , Guangzhou — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yanfeng Hu
- Email: yfenghu@qq.com
- Phone: 86+13632494551
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.