RecruitingNCT07295340

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

Application of Folic Acid-Targeted Near-Infrared-II (NIR-II) Carbon Dots in Ex Vivo Histopathological Analysis of Hepatocellular Carcinoma

Sponsor

West China Hospital

Enrollment

20 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Liver Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of glowing marker made from carbon dots to help surgeons and pathologists see liver cancer tissue more clearly in tissue samples removed during surgery, especially when tumor boundaries are hard to define. **You may be eligible if...** - You have been diagnosed with liver cancer (hepatocellular carcinoma) - You are scheduled for surgery to remove the tumor - Imaging scans (CT or MRI) suggest the tumor has unclear edges, an infiltrative pattern, or is close to major blood vessels **You may NOT be eligible if...** - You have a known allergy to the dye components - Your cancer has spread beyond the liver - You are not scheduled for surgical removal of the liver tumor - You have severe liver disease that makes surgery too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTEx Vivo FA-CDots Staining

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.