Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Molecular Imaging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Test: ICG-FTn perfusion solution | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Experimental: Indocyanine green-Ferritin (ICG-FTn)
- description
- Freshly resected gastric cancer specimens were perfused ex vivo via the gastric artery with the targeted probe FTn-ICG solution for about 10 minutes, followed by fluorescence imaging using a DPM system. The results were analyzed to identify tumor regions and delineate tumor margins.
- interventionNames
- Diagnostic Test: Diagnostic Test: ICG-FTn perfusion solution
Primary outcomes (1)
- measure
- The area under the curve (AUC) value of FTn-ICG for diagnostic performance
- timeFrame
- 2 years
- description
- Pathologists performed histopathological examination of the tumors, while researchers compared the margins identified by pathological results with those predicted by the fluorescence imaging of the probe to calculate the AUC value of ICG-FTn.
Secondary outcomes (3)
- measure
- Expression of the TfR1 in the tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Patients who have received neoadjuvant therapy; Patients deemed ineligible for participation by the investigator's assessment.
References
Publications (0)
Data not yet available