Gastric Cancer, Molecular Imaging
Conditions
Brief summary
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_TESTDiagnostic Test: ICG-FTn perfusion solution
The freshly resected gastric cancer specimens were arterially perfused with ICG-FTn solution and underwent fluorescence imaging.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under the curve (AUC) value of FTn-ICG for diagnostic performance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expression of the TfR1 in the tumor | 2 years | Ability of the imaging system to detect the expression of the TfR1 in tumor tissue. |
| FTn-ICG distribution in the tumor region | 2 years | Ability of the imaging system to identify tumor-specific uptake of the targeted probe. |
| Incidence rates of all adverse events (AEs) | 2 years | Tissue perfusion adverse events and adverse device events (ADEs) |
Countries
China
Contacts
Primary ContactYanfeng Hu
Outcome results
None listed