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
- Diseases
- Liver and biliary tract cancer
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing YouAn Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Tsinghua Changgeng Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Dazhou Central Hospital Coordinator of this site? Confirm its status | Dazhou | China | Recruiting |
| Meng Chao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Zhujiang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guizhou Provincial People's Hospital Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| The First People's Hospital of Yunnan Province Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Eastern Hepatobiliary Surgery Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shengjing Hospital Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Zhuhai People's Hospital Coordinator of this site? Confirm its status | Zhuhai | China | Recruiting |
| Fifth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Zhuhai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.