Application of Folic Acid-Targeted Near-Infrared-II (NIR-II) Carbon Dots in Ex Vivo Histopathological Analysis of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Diagnostic Performance of FA-CDots (Sensitivity, Specificity, and AUC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Diagnostic Performance of FA-CDots (Sensitivity, Specificity, and AUC)
时间窗: Immediate ex vivo analysis post-surgery
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.
次要结局
未报告次要终点
研究者
Jiwei Huang
Clinical Professor
West China Hospital