NCT07170345 Computer-Aided Diagnosis for Hepatocellular Carcinoma Microvascular Invasion
| NCT ID | NCT07170345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Academy of Sciences |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07170345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 18 Years, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07170345 currently recruiting?
Yes, NCT07170345 is actively recruiting participants. Contact the research team at di.dong@ia.ac.cn for enrollment information.
Where is the NCT07170345 trial being conducted?
This trial is being conducted at Fuzhou, China, Guangzhou, China, Guangzhou, China, Zhuhai, China and 11 additional locations.
Who is sponsoring the NCT07170345 clinical trial?
NCT07170345 is sponsored by Chinese Academy of Sciences. The trial plans to enroll 400 participants.
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