Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ex Vivo FA-CDots Staining | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Intervention group
- description
- Patients undergoing standard curative hepatectomy for HCC. Their resected tumor specimens will be used for ex vivo fluorescence imaging analysis.
- interventionNames
- Diagnostic Test: Ex Vivo FA-CDots Staining
Primary outcomes (1)
- measure
- Diagnostic Performance of FA-CDots (Sensitivity, Specificity, and AUC)
- timeFrame
- Immediate ex vivo analysis post-surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
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