Completed OBSERVATIONAL NCT07675525

Medical-AI trial: deep learning on repeated blood tests to catch liver fibrosis early (NIMIT-AI) — triage in fatty liver disease (MASLD) (NCT07675525)

Siriraj Hospital Updated 2026-06-30

An observational study of NIMIT-AI, which reads the trajectory of repeated blood tests with deep learning to identify liver scarring (fibrosis) early in fatty liver disease (MASLD), compared with the current FIB-4 score. Validated on patients seen at Siriraj Hospital in Bangkok in 2018–2022. Completed.

Trial overview (primary data)

  • StatusCompleted
  • ConditionsMASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
  • InterventionsDIAGNOSTIC_TEST: Longitudinal electronic health record analysis
  • SponsorSiriraj Hospital
  • Target enrollment1,351 participants
  • Period2018-01-01 〜 2024-06-16

Key points

  • An evaluation of NIMIT-AI, which reads the trajectory of repeated blood tests with deep learning to catch liver fibrosis early in MASLD.
  • Compared with the current FIB-4 score; primary endpoint is AUROC for identifying significant fibrosis (F>=2).
  • Validated on 969 patients seen at Siriraj Hospital in Bangkok, Thailand in 2018–2022.
  • Per the summary, in this testing NIMIT-AI identified fibrosis more accurately than FIB-4 and worked even with some missing lab values.
  • A single-center, retrospective validation; not an establishment of clinical use or FIB-4 replacement, with external reproduction as future work.

Fatty liver disease (MASLD, metabolic dysfunction-associated steatotic liver disease) is a common condition in which fat accumulates in the liver and, over time, causes scarring (fibrosis). Finding scarring early makes it easier to act before it worsens. The tool commonly used now is the FIB-4 score computed from blood tests, but it misses many patients and cannot be calculated when lab values are incomplete.

The NIMIT-AI program that this study evaluates takes a different angle. Per the registry summary, rather than a single set of values, NIMIT-AI reads blood-test results across multiple visits to capture patterns suggesting fibrosis.

It was tested on 969 patients seen at Siriraj Hospital in Bangkok, Thailand between 2018 and 2022, and the primary endpoint is the area under the ROC curve (AUROC) for identifying significant fibrosis (F>=2). According to the summary, in this testing NIMIT-AI identified fibrosis more accurately than FIB-4 and continued to work even when some lab values were missing (missing values occur often in real practice).

What stands out is the use of a temporal trajectory as the cue and the reported robustness to the missing data that is inherent to real care. Capturing changes that a single-timepoint score can miss, from the stream of lab values that accumulates with each visit, points toward AI that leverages the electronic health record (EHR).

That said, this is a single-center, retrospective validation, and the reported advantage is within that scope. It does not establish clinical use or replacement of FIB-4, and reproduction in external populations remains future work.

Why it matters

Using the trajectory of lab values across visits rather than a single reading, and being reported as robust to missing data, points toward AI that leverages the electronic health record (EHR). It is a useful reference for applying AI to chronic-disease triage (this trial is a single-center, retrospective validation, not an establishment of clinical use).

FAQ

What is the FIB-4 score?
An index that estimates the risk of liver fibrosis from age and blood-test values. It is simple but misses many patients and cannot be computed when lab values are incomplete.
Is it confirmed that NIMIT-AI is better than FIB-4?
No. It was reported as "more accurate" in a single-center, retrospective validation. It does not establish clinical use or replacement of FIB-4, and reproduction in external populations is needed.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Medical AI#Clinical trial#Deep learning#Liver#Fatty liver#Electronic health record
Disclaimer: This site independently summarizes and classifies information based on official data sources. Always verify the latest and accurate information with the official sources. Content on finance, health, legal, and security is information, not advice. This site is not an official website of the U.S. government.