RecruitingNCT07170345

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


Sponsor

Chinese Academy of Sciences

Enrollment

400 participants

Start Date

Sep 1, 2025

Study Type

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

Min Age: 18 YearsMax Age: 18 Years

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

DIAGNOSTIC_TESTComputer-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.


Locations(19)

Meng Chao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Zhujiang Hospital

Guangzhou, Guangdong, China

Fifth Affiliated Hospital, Sun Yat-Sen University

Zhuhai, Guangdong, China

Zhuhai People's Hospital

Zhuhai, Guangdong, China

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Shengjing Hospital

Shenyang, Liaoning, China

West China Hospital

Chengdu, Sichuan, China

Dazhou Central Hospital

Dazhou, Sichuan, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing Tsinghua Changgeng Hospital

Beijing, China

Beijing YouAn Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Eastern Hepatobiliary Surgery Hospital

Shanghai, China

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NCT07170345


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