Novel Humanized Ferritin-based NIR Fluorescent Molecular Probe for Identifying Tumor Margins in Gastric Tissue

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.

NCT Number	NCT07276854
Lead Sponsor	Nanfang Hospital, Southern Medical University
Conditions	Gastric Cancer, Molecular Imaging
Enrollment	32 participants
Start Date	2025-12-30
Primary Completion	2026-07-30 (estimated)
Study Completion	2026-08-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-11