RecruitingNot ApplicableNCT06859840

LEAF (Liver Tumor dEtection And classiFication AI)

Clinical Research on the Use of Non-contrast CT Combined With AI for Early Screening for Liver Malignancy


Sponsor

Zhejiang University

Enrollment

2,500 participants

Start Date

Jul 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to assess the feasibility of leveraging non-contrast CT and artificial intelligence to detect liver cancer in consecutive real-world patients. To this end, we deploy LEAF in a prospective real-world clinical setting for real-time monitoring, with a particular focus on flagging cases with liver cancer that may be missed by routine clinical workflow.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called LEAF(Liver tumor dEtection And classiFication AI) for people with liver malignancy. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELEAF(Liver tumor dEtection And classiFication AI)

The LEAF (Liver tumor dEtection And classiFication AI) model will assist in image interpretation. Patients with positive results for liver malignancy while not reported in standard-of-care CT report will be reviewed by a prespecified clinical action committee composed of hepatobiliary surgeons and abdominal radiologists will review the case and decide whether the AI finding warrants communication to the treating physician of these patients. For patients with suspected malignant liver tumors, the committee's consensus on the presence of suspicious lesions will be communicated to their attending physicians, who will then decide whether additional diagnostic assessment is indicated according to standard clinical practice, while remaining blinded to the LEAF results. The standard radiology workflow will not be altered by the study, and LEAF will be evaluated as a risk-stratification and case-flagging tool rather than a replacement for radiologist interpretation.


Locations(1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT06859840


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