Nanfang Hospital, Southern Medical University
Guangzhou, China
NCT Number: NCT07276854
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Guangzhou, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The freshly resected gastric cancer specimens were arterially perfused with ICG-FTn solution and underwent fluorescence imaging.
Time frame: 2 years
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.
Time frame: 2 years
Ability of the imaging system to detect the expression of the TfR1 in tumor tissue.
Time frame: 2 years
Ability of the imaging system to identify tumor-specific uptake of the targeted probe.
Time frame: 2 years
Tissue perfusion adverse events and adverse device events (ADEs)
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
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
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