NCT07295340Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 7 Dec 2025
- Start date
- Jan 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- West China Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07295340
What you commit to
- Study type: Observational
- Planned participants: 20
- From Jan 2026 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant other malignant tumors.
- Received preoperative anti-tumor therapy.
Other illness
- Severe dysfunction of heart, lung, kidney, or brain unable to tolerate surgery.
Other
- Recurrent HCC.
- Preoperative evidence of extrahepatic metastasis or major vascular invasion.
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.