Diagnostic Accuracy of Folate-Targeted NIR-II Carbon Dots for Ex Vivo HCC Detection

NCT07295340 | Recruiting

• 1 other identifier: JHuang20234
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Liver Cancer

Keywords

liver cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

resected liver specimens

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Jiwei Huang Professor

CONTACT

18980606725; huangjiwei@wchscu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)