Interventional AI-Human Collaboration for Steatotic Liver Disease Screening

Enrolling by invitation · Not applicable

Conditions studied: Steatotic Liver Disease, Liver Fibrosis Progression in Chronic Liver Disease, Liver Steatosis, Liver Fibrosis, Steatotic Liver Disease of Mixed Origin (MetALD)

In brief

Steatotic liver disease (SLD) is one of the most prevalent chronic liver diseases worldwide, affecting nearly 30% of the global population and projected to exceed 55% by 2040. Timely identification and management of intermediate- and high-risk SLD patients are essential, yet early detection remains challenging because current diagnostic modalities, such as biopsy, ultrasonography, and serum indices, are invasive, insensitive, operator-dependent, or difficult to scale. In contrast, non-contrast CT is widely available in routine care and offers substantial potential for opportunistic SLD screening, although this value has not been fully utilized. Our previously developed MAOSS model accurately identifies intermediate- and high-risk individuals, with MAOSS score≥1.6 combined with Fibro Score ≥1.7, demonstrating high sensitivity and specificity in our large-scale retrospective study. However, despite these promising retrospective findings, the model has not undergone prospective interventional validation, and it remains unclear whether an AI-guided workflow can truly enhance clinical risk stratification, diagnostic yield, and downstream management in real-world SLD populations. Therefore, a prospective intervention study is needed to determine whether MAOSS-guided identification and recall of at-risk individuals can meaningfully improve fibrosis detection and optimize clinical care pathways for SLD.

Key facts

Study ID

NCT07613827

Run by

Shengjing Hospital

People needed

7969

Starts

2026-02-24

Expected to finish

2027-02-24

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults aged ≥18 years undergoing routine non-contrast or contrast-enhanced chest or abdominal CT examination.
• CT images with adequate hepatic coverage and sufficient image quality for MAOSS analysis.
• Willing to undergo the recall evaluation and either: having a FIB-4 result within the past 1 month, or willing to complete blood testing (ALT, AST, platelet count) required for FIB-4 calculation and undergo FibroScan or MRE assessment.
• Willing to participate in the study and able to provide written informed consent at the time of recall.

You may not qualify if…

• Known malignant liver tumors (e.g., HCC, cholangiocarcinoma) or a history of liver transplantation or major hepatic resection.
• Known cirrhosis based on noninvasive fibrosis assessment tests, liver biopsy or complications of decompensated disease, or with a documented history of cirrhosis identified by clinical notes will be excluded.
• Biliary obstruction, acute cholangitis, or other conditions that may interfere with interpretation of liver biochemistry or fibrosis risk assessment.
• CT images with severe artifacts or incomplete liver coverage preventing reliable MAOSS analysis.
• Severe acute systemic illness (e.g., sepsis, shock, acute heart failure), or pregnancy or breastfeeding.
• Unwilling or unable to complete recall procedures, including required blood tests, FibroScan, or MRE when indicated, or unable to comply with study follow-up.
• Severe comorbidity with an expected survival of less than 1 year (e.g., terminal malignancy).

Where it is running

• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China

Full record on ClinicalTrials.gov

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