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
West China Hospital
20 participants
Jan 1, 2026
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- Primary diagnosis of Hepatocellular Carcinoma (HCC) confirmed clinically or by preoperative biopsy.
- Scheduled for radical hepatectomy.
- Preoperative imaging (CT/MRI) suggests indistinct tumor boundaries, infiltrative growth, or proximity to major vessels (expected margin \< 1cm).
- Liver function classified as Child-Pugh Grade A.
- ASA Physical Status classification I-III.
- Participant or legal guardian willing to sign informed consent for the use of ex vivo tissues.
Exclusion Criteria6
- Concomitant other malignant tumors.
- Severe dysfunction of heart, lung, kidney, or brain unable to tolerate surgery.
- Recurrent HCC.
- Preoperative evidence of extrahepatic metastasis or major vascular invasion.
- Received preoperative anti-tumor therapy.
- Pregnant or lactating women.
Interventions
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.
Locations(1)
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NCT07295340