Novel Humanized Ferritin-based NIR Fluorescent Molecular Probe for Identifying Tumor Margins in Gastric Tissue
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic Test: ICG-FTn perfusion solution.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Molecular Imaging. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Diagnostic test Diagnostic Test: ICG-FTn perfusion solution
The freshly resected gastric cancer specimens were arterially perfused with ICG-FTn solution and underwent fluorescence imaging.
Primary outcome measures
- The area under the curve (AUC) value of FTn-ICG for diagnostic performance [Time frame: 2 years]
Secondary outcome measures (3)
- Expression of the TfR1 in the tumor [Time frame: 2 years]
- FTn-ICG distribution in the tumor region [Time frame: 2 years]
- Incidence rates of all adverse events (AEs) [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Nanfang Hospital, Southern Medical University — Guangzhou
Identifiers
NCT: NCT07276854 · NFEC-2025-243