RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form for the use of ex vivo tissues. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIAGNOSTIC_TEST

Ex 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.

Locations (1)

West China Hospital

Chengdu, Sichuan, China