Diagnostic Accuracy of Folate-Targeted NIR-II Carbon Dots for Ex Vivo HCC Detection

Sponsor
West China Hospital
Study ID
NCT07295340
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ex Vivo FA-CDots Staining — DIAGNOSTIC_TEST
    The resected liver specimens are incubated with Folate-targeted Near-Infrared II Carbon Dots (FA-CDots) and imaged using a NIR-II fluorescence imaging system to identify tumor margins and micro-lesions. The results are compared with standard histopathology.

Study Details

This prospective, single-center observational study evaluates the diagnostic accuracy of a novel Folate-targeted Near-Infrared II Carbon Dot (FA-CDots) probe for the ex vivo assessment of Hepatocellular Carcinoma (HCC). Following standard radical hepatectomy, resected liver specimens will be incubated with the FA-CDots probe and imaged using a NIR-II fluorescence system. The study aims to determine the feasibility and accuracy of this technology in identifying tumor margins and micro-lesions by comparing the fluorescence imaging results with standard histopathological examination.

Key Dates

First listed
Dec 19, 2025
Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Apr 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Intervention group
    Patients undergoing standard curative hepatectomy for HCC. Their resected tumor specimens will be used for ex vivo fluorescence imaging analysis.

Primary Outcome Measure

Diagnostic Performance of FA-CDots (Sensitivity, Specificity, and AUC) [ Time Frame: Immediate ex vivo analysis post-surgery ]

Central Contacts

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