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AI Models vs Non-Invasive Fibrosis Scores in MAFLD Diagnosis

Assessing the Utility of AI Models in MAFLD Diagnosis: Comparison With Traditional Non-Invasive Fibrosis Scores.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07305636
Acronym
MAFLD-AI
Enrollment
522
Registered
2025-12-26
Start date
2025-05-13
Completion date
2025-11-30
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AI (Artificial Intelligence), MAFLD

Brief summary

This study evaluates the accuracy of artificial intelligence (AI) models using FibroScan and clinical data to predict hepatic fibrosis in Egyptian patients with metabolic-associated fatty liver disease (MAFLD). The performance of the AI models will be compared with conventional noninvasive fibrosis scores (FIB-4, APRI, NAFLD fibrosis score, and FAST). The goal is to improve early, noninvasive diagnosis of fibrosis and reduce reliance on liver biopsy.

Interventions

None listed

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Days to No maximum

Inclusion criteria

\- Adults ≥18 years. Diagnosed with MAFLD according to international criteria (hepatic steatosis with metabolic dysfunction). Valid FibroScan evaluation with available LSM and CAP values.

Exclusion criteria

* Excessive alcohol intake (\>30 g/day for men, \>20 g/day for women). Chronic viral hepatitis (HBV or HCV). Autoimmune hepatitis. Known malignancy. Pregnancy. Refusal to participate.

Design outcomes

Primary

MeasureTime frame
Measure diagnostic accuracy of AI models in predicting hepatic fibrosis stage (F0-F4)At enrollment (single cross-sectional assessment).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026