Folate-targeted NIR-II carbon dot imaging to detect HCC in removed liver tissue

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

This will test a folate-targeted near-infrared probe on removed liver tissue to see if it helps identify hepatocellular carcinoma margins and tiny lesions in patients undergoing radical hepatectomy.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07295340 on ClinicalTrials.gov

What this trial studies

This prospective, single-center observational study applies a folate-targeted NIR-II carbon dot (FA-CDots) probe to freshly resected liver specimens from patients with confirmed or suspected hepatocellular carcinoma. Resected specimens are incubated ex vivo with the FA-CDots probe and imaged using a near-infrared II fluorescence system. Fluorescence imaging findings will be compared directly with standard histopathology to measure diagnostic accuracy for tumor margins and micro-lesions. The protocol enrolls patients scheduled for radical hepatectomy with preoperative imaging suggesting indistinct boundaries or infiltrative growth.

Who should consider this trial

Good fit: Ideal candidates are adults with primary hepatocellular carcinoma scheduled for radical hepatectomy, Child-Pugh Grade A liver function, ASA I-III, and preoperative imaging suggesting indistinct tumor boundaries or proximity to major vessels who consent to ex vivo tissue use.

Not a fit: Patients with recurrent HCC, extrahepatic metastasis or major vascular invasion, prior preoperative anti-tumor therapy, concurrent other malignancies, severe organ dysfunction, or who are pregnant or lactating are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the technique could help pathologists and surgeons detect tumor margins and tiny cancer foci more accurately in resected livers, potentially reducing missed disease and guiding better postoperative care.

How similar studies have performed: Preclinical and early clinical work with NIR-II agents and folate-targeted probes has shown promising results for tumor visualization, but ex vivo FA-CDots specifically for HCC margin detection is novel and not yet validated in larger clinical series.

Eligibility criteria

Inclusion Criteria:

1. Primary diagnosis of Hepatocellular Carcinoma (HCC) confirmed clinically or by preoperative biopsy.
2. Scheduled for radical hepatectomy.
3. Preoperative imaging (CT/MRI) suggests indistinct tumor boundaries, infiltrative growth, or proximity to major vessels (expected margin \< 1cm).
4. Liver function classified as Child-Pugh Grade A.
5. ASA Physical Status classification I-III.
6. Participant or legal guardian willing to sign informed consent for the use of ex vivo tissues.

Exclusion Criteria:

1. Concomitant other malignant tumors.
2. Severe dysfunction of heart, lung, kidney, or brain unable to tolerate surgery.
3. Recurrent HCC.
4. Preoperative evidence of extrahepatic metastasis or major vascular invasion.
5. Received preoperative anti-tumor therapy.
6. Pregnant or lactating women.

Where this trial is running

Chengdu, Sichuan

• West China Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Jiwei Huang Professor

Conditions Liver Cancer; liver cancer