Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07295340

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

Led by West China Hospital · Updated on 2025-12-19

20

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary diagnosis of Hepatocellular Carcinoma (HCC) confirmed clinically or by preoperative biopsy
  • Scheduled for radical hepatectomy
  • Preoperative imaging (CT/MRI) shows indistinct tumor boundaries, infiltrative growth, or tumor close to major vessels with expected margin less than 1 cm
  • Liver function classified as Child-Pugh Grade A
  • ASA Physical Status classification I-III
  • Participant or legal guardian willing to sign informed consent for use of ex vivo tissues
Not Eligible

You will not qualify if you...

  • Presence of other malignant tumors
  • Severe dysfunction of heart, lung, kidney, or brain that prevents tolerating surgery
  • Recurrent Hepatocellular Carcinoma
  • Preoperative evidence of cancer spread outside liver or major blood vessel invasion
  • Received anti-tumor treatment before surgery
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

West China Hospital

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

J

Jiwei Huang Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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