Humanized ferritin near‑infrared fluorescent probe to find sentinel lymph node metastases in early gastric cancer
Official title: A Humanized Ferritin-Based NIR Fluorescent Probe for Discrimination Between Benign and Malignant Sentinel Lymph Nodes in Early Gastric Cancer
Run by Nanfang Hospital, Southern Medical University · NCT07294638 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 47 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | July 15, 2025 |
| Main results expected | July 1, 2026 |
| Study ends | July 7, 2026 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT07294638 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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).
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 gone: 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.
Who can join: the full rules
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 it's running
-
Nanfang Hospital, Southern Medical University , Guangzhou
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Yanfeng Hu
- Email: yfenghu@qq.com
- Phone: 86+13632494551
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.