Computer-Aided Diagnosis for Hepatocellular Carcinoma Microvascular Invasion

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-18
SponsorChinese Academy of Sciences

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

400 Participants
are divided into 19 treatment groups

19

Treatment groups

See each treatment group below.

Sponsors and collaborators

Chinese Academy of Sciences

Lead sponsor

Peking Union Medical College Hospital

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator

Beijing YouAn Hospital

Collaborator

Zhujiang Hospital

Collaborator

Meng Chao Hepatobiliary Hospital of Fujian Medical University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

Henan Provincial People's Hospital

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborator

Shengjing Hospital

Collaborator

Beijing Tsinghua Changgeng Hospital

Collaborator

Yunnan Cancer Hospital

Collaborator

The First People's Hospital of Yunnan

Collaborator

Guizhou Provincial People's Hospital

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

West China Hospital

Collaborator

ZhuHai Hospital

Collaborator

Dazhou Central Hospital

Collaborator

Eastern Hepatobiliary Surgery Hospital

Collaborator