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Recruiting NCT07295340

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

— Observational Liver Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ex Vivo FA-CDots Staining.
Who it may be relevant to
Registry conditions: Liver Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Diagnostic Performance of FA-CDots (Sensitivity, Specificity, and AUC) [Time frame: Immediate ex vivo analysis post-surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • West China Hospital — Chengdu

Identifiers

NCT: NCT07295340 · JHuang20234

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗