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

West China Hospital20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Cancer

Interventions

Ex Vivo FA-CDots StainingDIAGNOSTIC_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.

Eligibility

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Diagnostic Performance of FA-CDots (Sensitivity, Specificity, and AUC)

Evaluate the accuracy of FA-CDots in distinguishing HCC tissue from normal liver tissue. Metric: Area Under the Receiver Operating Characteristic Curve (AUC), Sensitivity, and Specificity. Calculation: Based on the Signal-to-Background Ratio (SBR) of the fluorescence images. A "Positive" result is defined as an SBR \> 2.0 (threshold to be optimized). Gold Standard: The diagnosis is verified by standard histopathological examination (H\&E staining) of the corresponding tissue sites.

Time frame: Immediate ex vivo analysis post-surgery