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NCT07170345Recruiting

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

Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
28 Aug 2025
Start date
1 Sept 2025
Primary completion date
1 Sept 2026
Lead sponsor
Chinese Academy of Sciences
NCT number
NCT07170345

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 1 Sept 2025 to the primary completion date, 1 Sept 2026
  • 19 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of prior antitumor treatment, including preoperative surgical intervention, transarterial chemoembolization (TACE), radiofrequency ablation (RFA), systemic therapy, or any other preoperative intervention.

Other illness

  • Presence of major vascular invasion, bile duct invasion/thrombosis, extrahepatic metastasis, or lymph node involvement.
  • Diffuse hepatocellular carcinoma or tumor rupture with hemorrhage.

Other

  • Lack of key data required for primary analysis.
  • Poor image quality that prevents reliable qualitative or radiomics analysis.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing YouAn Hospital
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BeijingChinaRecruiting
Beijing Tsinghua Changgeng Hospital
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BeijingChinaRecruiting
Peking Union Medical College Hospital
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BeijingChinaRecruiting
West China Hospital
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ChengduChinaRecruiting
Dazhou Central Hospital
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DazhouChinaRecruiting
Meng Chao Hepatobiliary Hospital of Fujian Medical University
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FuzhouChinaRecruiting
Zhujiang Hospital
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GuangzhouChinaRecruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
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GuangzhouChinaRecruiting
Guizhou Provincial People's Hospital
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GuiyangChinaRecruiting
The First People's Hospital of Yunnan Province
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KunmingChinaRecruiting
Yunnan Cancer Hospital
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KunmingChinaRecruiting
First Affiliated Hospital of Kunming Medical University
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KunmingChinaRecruiting
First Affiliated Hospital of Guangxi Medical University
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NanningChinaRecruiting
Eastern Hepatobiliary Surgery Hospital
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ShanghaiChinaRecruiting
Shengjing Hospital
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ShenyangChinaRecruiting
First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Henan Provincial People's Hospital
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ZhengzhouChinaRecruiting
Zhuhai People's Hospital
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ZhuhaiChinaRecruiting
Fifth Affiliated Hospital, Sun Yat-sen University
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ZhuhaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.