Computer-Aided Diagnosis for Hepatocellular Carcinoma Microvascular Invasion

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.

NCT Number	NCT07170345
Lead 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)
Enrollment	400 participants
Start Date	2025-09-01
Primary Completion	2026-09-01 (estimated)
Study Completion	2027-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-12