Computer-Aided Diagnosis for Hepatocellular Carcinoma Microvascular Invasion

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.

Conditions

• Hepatocellular Carcinoma (HCC)
• Microvascular Invasion (MVI)

Interventions

DIAGNOSTIC_TEST

Computer-Aided Diagnosis System for Preoperative Prediction of MVI in HCC

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Beijing YouAn Hospital

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Meng Chao Hepatobiliary Hospital of Fujian Medical University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Beijing Tsinghua Changgeng Hospital

  collaborator OTHER

• Yunnan Cancer Hospital

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• Dazhou Central Hospital

  collaborator OTHER

• Eastern Hepatobiliary Surgery Hospital

  collaborator OTHER

• Chinese Academy of Sciences

  lead OTHER_GOV

Eligibility

Min Age

18 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2026-09-01

Completion

2027-09-01

Countries

• China

Study Locations