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

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 Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Diagnostic test: Ex Vivo FA-CDots Staining

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Jiwei Huang Professor; Phone Number: 18980606725; Email: huangjiwei@wchscu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital
      • Contact: Jiwei Huang Professor; Phone Number: 18980606725; Email: huangjiwei@wchscu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-80 diagnosed with hepatocellular carcinoma (HCC) who are scheduled for radical hepatectomy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention group; Patients undergoing standard curative hepatectomy for HCC. Their resected tumor specimens will be used for ex vivo fluorescence imaging analysis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: liver cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: JHuang20234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No