NCT07276854Not yet recruiting
Novel Humanized Ferritin-based NIR Fluorescent Molecular Probe for Identifying Tumor Margins in Gastric Tissue
Study of a Novel Near-Infrared (NIR) Fluorescent Molecular Probe Based on Humanized Ferritin for the Identification of Benign and Malignant Margins in Gastric Tissue
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
Radical surgery remains the primary treatment for gastric cancer, but intraoperative tumor margin assessment relies on surgeons' visual inspection, limiting accuracy. There is thus an urgent clinical need for real-time visualisation of tumour margins. In recent years, near-infrared (NIR) fluorescence imaging has emerged as a critical tool for precision tumor resection. However, existing probes like indocyanine green (ICG) lack tumor-targeting specificity. Ferritin (FTn), with its unique nanocage structure, excellent biosafety, and well-defined in vivo behavior, presents an attractive platform for targeted molecular probes. Yet, translational challenges persist, including animal model limitations and clinical validation bottlenecks. To address this, our study employs freshly resected human gastric tissue in an ex vivo perfusion system, simulating the circulatory dynamics of the humanized ferritin-based probe FTn-ICG in vivo. Using a prospective clinical sample cohort, we aim to validate its diagnostic efficacy in delineating gastric cancer margins, ultimately overcoming the critical barrier of precise tumor boundary identification.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 32 (estimated)
- First submitted
- 30 Nov 2025
- Start date
- 30 Dec 2025
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07276854
What you commit to
- Study type: Observational
- Planned participants: 32
- From 30 Dec 2025 to the primary completion date, 30 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received neoadjuvant therapy; Patients deemed ineligible for participation by the investigator's assessment.
Who the study is looking for
- Pathologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma eligible for radical resection, with histologically verified predominant adenocarcinoma component; Age ≥ 18 years; No gender restriction ; Voluntary participation with written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.