Computer-Aided Diagnosis for Hepatocellular Carcinoma Microvascular Invasion
Development of a Computer-Aided Diagnosis System for Hepatocellular Carcinoma Microvascular Invasion Based on Preoperative Image Analysis
Chinese Academy of Sciences
400 participants
Sep 1, 2025
OBSERVATIONAL
Conditions
Summary
Hepatocellular carcinoma (HCC) is a common malignancy in China with a high mortality rate. Its early recurrence and long-term prognosis are closely associated with tumor aggressiveness. Microvascular invasion (MVI), defined as the presence of tumor cells within small branches of the portal or hepatic veins, is a key indicator of malignant biological behavior in HCC. Clinically, MVI is strongly correlated with postoperative early recurrence and serves as an important factor in determining surgical margin extension, adjuvant therapy, and postoperative management strategies. At present, definitive diagnosis of MVI still relies on postoperative pathological examination, and stable, effective preoperative assessment methods are lacking. Although some studies have attempted to predict MVI using preoperative imaging features, their clinical translation remains limited by poor generalizability, weak interpretability, and insufficient cross-center adaptability. This study aims to leverage multiphase preoperative CT imaging, artificial intelligence techniques, and clinical prior knowledge to develop a high-performance, generalizable, and interpretable computer-aided diagnostic system for preoperative prediction of HCC-MVI. An observational, prospective evaluation will be conducted to assess system performance and to facilitate the clinical translation of intelligent diagnostic technologies in real-world practice.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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.
Interventions
This intervention is an artificial intelligence-based computer-aided diagnosis (CAD) system developed to predict microvascular invasion (MVI) in patients with hepatocellular carcinoma using preoperative multiphase CT imaging. The system integrates deep learning, radiomics, and expert-defined imaging features to provide risk assessment and visualization of MVI prior to surgery. In this study, the CAD system will be evaluated retrospectively and prospectively in an observational manner only. The results will not influence clinical decision-making or patient management, and all treatments will follow standard of care.
Locations(19)
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NCT07170345