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

NCT07276854 | Not Yet Recruiting DMC

• 1 other identifier: NFEC-2025-243
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Molecular Imaging

Outcome Measures

Primary Outcomes (1)

• The area under the curve (AUC) value of FTn-ICG for diagnostic performance

  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.

  2 years

Secondary Outcomes (3)

• Expression of the TfR1 in the tumor

  2 years

• FTn-ICG distribution in the tumor region

  2 years

• Incidence rates of all adverse events (AEs)

  2 years

Study Arms (1)

Experimental: Indocyanine green-Ferritin (ICG-FTn)

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.

Diagnostic Test: Diagnostic Test: ICG-FTn perfusion solution

Interventions

Diagnostic Test: ICG-FTn perfusion solution DIAGNOSTIC_TEST

The freshly resected gastric cancer specimens were arterially perfused with ICG-FTn solution and underwent fluorescence imaging.

Experimental: Indocyanine green-Ferritin (ICG-FTn)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was recruited from the Nanfang Hospital of Southern Medical University in Guangzhou, China.

You may qualify if:

• 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.

You may not qualify if:

• Patients who have received neoadjuvant therapy; Patients deemed ineligible for participation by the investigator's assessment.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Yanfeng Hu

CONTACT

+86 13632494551; yfenghu@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)