Development of a Computer-Aided Diagnosis System for Hepatocellular Carcinoma Microvascular Invasion Based on Preoperative Image Analysis
Trial ID: NCT07170345
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-09-01
Completion date: 2027-09-01
Sponsor: Chinese Academy of Sciences
Collaborators: Peking Union Medical College Hospital; First Affiliated Hospital of Kunming Medical University; Beijing YouAn Hospital; Zhujiang Hospital; Meng Chao Hepatobiliary Hospital of Fujian Medical University; First Affiliated Hospital of Wenzhou Medical University; Fifth Affiliated Hospital, Sun Yat-Sen University; Henan Provincial People's Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Shengjing Hospital; Beijing Tsinghua Changgeng Hospital; Yunnan Cancer Hospital; The First People's Hospital of Yunnan; Guizhou Provincial People's Hospital; First Affiliated Hospital of Guangxi Medical University; West China Hospital; ZhuHai Hospital; Dazhou Central Hospital; Eastern Hepatobiliary Surgery Hospital
Conditions: Hepatocellular Carcinoma (HCC); Microvascular Invasion (MVI)
Interventions: Computer-Aided Diagnosis System for Preoperative Prediction of MVI in HCC
Locations: Meng Chao Hepatobiliary Hospital of Fujian Medical University; Guangdong Provincial Hospital of Traditional Chinese Medicine; Zhujiang Hospital; Fifth Affiliated Hospital, Sun Yat-Sen University; Zhuhai People's Hospital; First Affiliated Hospital of Guangxi Medical University; Guizhou Provincial People's Hospital; Henan Provincial People's Hospital; Shengjing Hospital; West China Hospital; Dazhou Central Hospital; First Affiliated Hospital of Kunming Medical University; The First People's Hospital of Yunnan Province; Yunnan Cancer Hospital; First Affiliated Hospital of Wenzhou Medical University; Beijing Tsinghua Changgeng Hospital; Beijing YouAn Hospital; Peking Union Medical College Hospital; Eastern Hepatobiliary Surgery Hospital
Countries: China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China
Enrollment: 400
Age range: 18 Years - 18 Years
Sex: ALL

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 criteria:
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.

Outcomes:
Area Under the Receiver Operating Characteristic Curve (AUC); Accuracy