AI-based CT prediction of microvascular invasion in liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study developing and validating a computer-aided diagnostic (CAD) system that combines deep learning image features, predefined imaging signatures, and clinical prior knowledge from multiphase CT scans to predict microvascular invasion (MVI) in HCC. Participants are adults with confirmed HCC who undergo preoperative multiphase CT within one month before planned hepatic resection or transplantation and have postoperative histopathology documenting MVI status. The CAD system's predictions will be compared to the gold-standard postoperative pathology to measure diagnostic performance and cross-center generalizability. The study emphasizes interpretability and adaptability across multiple Chinese hospitals to improve clinical applicability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Confirmed diagnosis of hepatocellular carcinoma (HCC) according to the Chinese Clinical Practice Guidelines for Primary Liver Cancer.
* Eligible for surgical intervention (hepatic resection or liver transplantation) according to the Chinese Clinical Practice Guidelines for Cancer, including stages Ia, Ib, and IIa.
* Preoperative imaging examination performed within 1 month before surgery.
* Availability of histopathological evaluation with documented microvascular invasion (MVI) status.

Exclusion Criteria:

* History of prior antitumor treatment, including preoperative surgical intervention, transarterial chemoembolization (TACE), radiofrequency ablation (RFA), systemic therapy, or any other preoperative intervention.
* Presence of major vascular invasion, bile duct invasion/thrombosis, extrahepatic metastasis, or lymph node involvement.
* Diffuse hepatocellular carcinoma or tumor rupture with hemorrhage.
* Lack of key data required for primary analysis.
* Poor image quality that prevents reliable qualitative or radiomics analysis.

Where it's running

• Meng Chao Hepatobiliary Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• Guangdong Provincial Hospital of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Recruiting
• Zhujiang Hospital
  Guangzhou, Guangdong, China Recruiting
• Fifth Affiliated Hospital, Sun Yat-Sen University
  Zhuhai, Guangdong, China Recruiting
• Zhuhai People's Hospital
  Zhuhai, Guangdong, China Recruiting
• First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting

Study contacts

• Study coordinator: Di Dong, Ph.D.
• Email: di.dong@ia.ac.cn
• Phone: +86 13811833760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.