Computer-Aided Diagnosis for Hepatocellular Carcinoma Microvascular Invasion

Recruiting now

Conditions studied: Hepatocellular Carcinoma (HCC), Microvascular Invasion (MVI)

In brief

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.

Key facts

Study ID

NCT07170345

Run by

Chinese Academy of Sciences

People needed

400

Starts

2025-09-01

Expected to finish

2027-09-01

Last updated by the study team

2025-09-12

Who can join

Age: 18 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Meng Chao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (enrolling)
• Zhujiang Hospital — Guangzhou, Guangdong, China (enrolling)
• Fifth Affiliated Hospital, Sun Yat-Sen University — Zhuhai, Guangdong, China (enrolling)
• Zhuhai People's Hospital — Zhuhai, Guangdong, China (enrolling)
• First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• Shengjing Hospital — Shenyang, Liaoning, China (enrolling)
• West China Hospital — Chengdu, Sichuan, China (enrolling)
• Dazhou Central Hospital — Dazhou, Sichuan, China (enrolling)
• First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
• The First People's Hospital of Yunnan Province — Kunming, Yunnan, China (enrolling)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (enrolling)
• First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)
• Beijing Tsinghua Changgeng Hospital — Beijing, China (enrolling)
• Beijing YouAn Hospital — Beijing, China (enrolling)
• Peking Union Medical College Hospital — Beijing, China (enrolling)
• Eastern Hepatobiliary Surgery Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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