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

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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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Jiwei Huang Professor

CONTACT

[email protected]

18980606725

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

Diagnostic Performance of FA-CDots (Sensitivity, Specificity, and AUC)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiwei Huang Professor

CONTACT

[email protected]

18980606725

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Application of Folic Acid-Targeted Near-Infrared-II (NIR-II) Carbon Dots in Ex Vivo Histopathological Analysis of Hepatocellular Carcinoma

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Dec 19, 2025
Registry last updated: Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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