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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Patients undergoing standard curative hepatectomy for HCC. Their resected tumor specimens will be used for ex vivo fluorescence imaging analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ex Vivo FA-CDots Staining | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate ex vivo analysis post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 18-80 diagnosed with hepatocellular carcinoma (HCC) who are scheduled for radical hepatectomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiwei Huang Professor | Contact | 18980606725 | huangjiwei@wchscu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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resected liver specimens
|
| D008107 |
| Liver Diseases |