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

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 Criteria:

1. Primary diagnosis of Hepatocellular Carcinoma (HCC) confirmed clinically or by preoperative biopsy.
2. Scheduled for radical hepatectomy.
3. Preoperative imaging (CT/MRI) suggests indistinct tumor boundaries, infiltrative growth, or proximity to major vessels (expected margin \< 1cm).
4. Liver function classified as Child-Pugh Grade A.
5. ASA Physical Status classification I-III.
6. Participant or legal guardian willing to sign informed consent for the use of ex vivo tissues.

Exclusion Criteria:

1. Concomitant other malignant tumors.
2. Severe dysfunction of heart, lung, kidney, or brain unable to tolerate surgery.
3. Recurrent HCC.
4. Preoperative evidence of extrahepatic metastasis or major vascular invasion.
5. Received preoperative anti-tumor therapy.
6. Pregnant or lactating women.

Conditions3

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