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NCT Number: NCT06859840

LEAF (Liver Tumor dEtection And classiFication AI)

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.

Recruiting

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Qi Zhang

CONTACT

[email protected]

13858108798

About this study

This prospective real-world trial will be conducted at FAHZU, a high-volume tertiary medical center in mainland China.

LEAF will be deployed within the hospital information system through the DAMO Intelligent Medical Imaging interface, allowing it to flag potential liver lesions in real time. Approximately 2500 consecutive patients undergoing non-contrast CT examinations will be enrolled starting in July 2026. All incoming non-contrast chest and abdominal CT scans will be simultaneously reviewed by radiologists in routine clinical workflow and processed by LEAF in real-time. Daily logs of LEAF-positive alerts will be maintained by the research team. A prespecified clinical action committee composed of hepatobiliary surgeons and abdominal radiologists will review the case to assess 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age range 18 years and above;

Underwent non-contrast chest or abdominal CT examination with liver coverage;

Patients with an established diagnosis of cirrhosis;

Patients with an established diagnosis of extrahepatic cancer.

Exclusion criteria

Patients who have been diagnosed with malignant liver tumor;

Patients who underwent liver transplantation;

Low quality image, severe artifacts and noise.

Treatment and study plan

LEAF(Liver tumor dEtection And classiFication AI)

Device

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.

Primary outcomes

  1. Detection accuracy in liver tumor assisted by LEAF (Liver tumor dEtection And classiFication AI)

    Time frame: Within 4 weeks after enrollment

    Sensitivity, specificity of liver malignancy identification (defined as liver malignancy vs. liver benign tumor and non-tumor)

Secondary outcomes

  1. AI diagnostic performance: patient-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of liver malignancy identification

    Time frame: Within 4 weeks after enrollment

  2. Clinical utility: number of AI-detected and originally overlooked liver malignant lesions

    Time frame: Within 4 weeks after enrollment

    recalled and pathologically confirmed

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Zhang

CONTACT

[email protected]

13819137113

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Acronym: LEAF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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