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Interventional AI-Human Collaboration for Steatotic Liver Disease Screening

23 mei 2026 bijgewerkt door: Yu Shi, Shengjing Hospital

AI-Driven Opportunistic Screening and Risk-Adapted Management of Steatotic Liver Disease

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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The AIG-SLD Screening Project is a single-arm, open-label, prospective interventional study designed to evaluate the effectiveness of a MAOSS-guided identification and AI-human collaboration recall strategy for detecting individuals at intermediate or high risk of steatotic liver disease (SLD) and for assessing intervention outcomes. The trail will prospectively and consecutively enroll around 8000 eligible adults aged ≥18 years who undergo routine chest or abdominal non-contrast CT (NCCT) with adequate hepatic coverage .

The AI system i.e. MAOSS will be embedded within the standard clinical workflow to evaluate the real-world performance and the impact of AIG-SLD screening. All eligible NCCT scans will be evaluated through two parallel streams:

  1. Standard of Care (SoC) workflow: Radiologists perform independent assessments, first-line radiologists review followed by a senior radiologist finalizing the report.
  2. AIG workflow: The MAOSS system simultaneously analyzes the identical imaging data in real-time.

The system screens patients with clinically suspected SLD by flagging those with a MAOSS score ≥1.6 and a FIBRO Score ≥1.7 for recall. These algorithmic flags will be compared against radiologists' determinations of clinically significant SLD. Management pathways are defined as follows: (1) Concordant cases: If the Standard of Care (SoC) and the AIG pathway agree (both recommending recall or both recommending no recall), the agreed-upon decision will be executed. (2) Discordant cases: If the SoC and AIG pathways disagree, patients will be recalled for primary hepatology care to ensure safety.

Primary hepatology care begins with the collection of questionnaires regarding medical history, lifestyle, alcohol consumption, and metabolic risks (Type 2 Diabetes Mellitus, obesity, metabolic syndrome, significant alcohol consumption, or viral hepatitis) followed by further serum laboratory tests and Transient Elastography (e.g., FibroScan). Recalled patients will be managed according to the MAOSS pathway starting with FIB-4 stratification (<1.3, 1.3-2.67, >2.67), followed by FAST stratification (<0.35, ≥0.35) as needed. Intermediate-to-high-risk patients will proceed to escalated care involving MRE, MRI-PDFF, or liver biopsy. Management is then determined by MRE-derived Liver Stiffness Measurement (LSM): patients with LSM < 3.5 kPa will receive lifestyle interventions and annual reassessment; those with LSM 3.5-5.0 kPa (F2-F3) will receive pharmacological or therapeutic interventions; and those with LSM ≥ 5.0 kPa (F4) will undergo cirrhosis-based management. Patients in the latter two groups will be reassessed every six months to monitor changes in steatosis and fibrosis.

Studietype

Ingrijpend

Inschrijving (Geschat)

7969

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Screening
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: AI-human collaboration for SLD screening
In the prospective analysis phase, all eligible NCCT scans will be evaluated through two parallel streams: 1. Standard of Care (SoC) workflow: Radiologists perform independent assessments as per standard clinical procedures (e.g., first-line radiologists' reviews followed by senior radiologist finalizing the report). 2. AIG workflow: The MAOSS system simultaneously analyzes the identical imaging data in real-time.
Diagnostische toets: AI-human collaboration for SLD screening
The system screens patients with clinically suspected SLD by flagging those with a MAOSS score ≥1.6 and a FIBRO Score ≥1.7 for recall. These algorithmic flags will be compared against radiologists' determinations of clinically significant SLD. Management pathways are defined as follows: (1) Concordant cases: If the Standard of Care (SoC) and the AIG pathway agree (both recommending recall or both recommending no recall), the agreed-upon decision will be executed. (2) Discordant cases: If the SoC and AIG pathways disagree, patients will be recalled for primary hepatology care to ensure safety and avoid potential missed diagnosis.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effective referral yield for escalated hepatology care
Tijdsspanne: 6 months
Effective referral yield: the proportion of patients referred for escalated hepatology care confirmed with clinically significant (or above) fibrosis by MRE/liver biposy. A non-inferiority test (and estimates of the associated absolute and relative differences) will be performed for effective referral yield between SoC and AIG workflow.
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Real-World Screening Specificity
Tijdsspanne: Duration of the study (12 months)
A critical safety endpoint is to determine if AIG-SLD care pathway maintains a high specificity to prevent false referral, thereby avoiding unnecessary interventions.
Duration of the study (12 months)
Real-World Screening Sensitivity
Tijdsspanne: Duration of the study (12 months)
A critical efficacy endpoint is to determine if AIG-SLD care pathway is sufficiently sensitive to identify patients who actually need interventions.
Duration of the study (12 months)
Real-World Screening Negative predictive value
Tijdsspanne: Duration of the study (12 months)
This evaluates the AIG-SLD care pathway's ability to correctly exclude low-risk patients who actually do not need interventions.
Duration of the study (12 months)
Intervention Success (Fibrosis Reversion)
Tijdsspanne: Duration of the study (12 months)
The proportion of patients referred for escalated care achieves fibrosis stage reversion.
Duration of the study (12 months)
Intervention Success (Steatosis Reversion)
Tijdsspanne: Duration of the study (12 months)
The proportion of patients referred for escalated care achieves steatosis stage Reversion.
Duration of the study (12 months)
Quantitative Liver Stiffness Trends
Tijdsspanne: Duration of the study (12 months)
The overall longitudinal changes in Liver Stiffness Measurement (LSM) values for all patients referred to escalated care.
Duration of the study (12 months)
Quantitative Liver Steatosis Trends
Tijdsspanne: Duration of the study (12 months)
The overall longitudinal changes in Liver Fat Content (CAP/PDFF) values for all patients referred to escalated care.
Duration of the study (12 months)
Intervention Patient Adherence
Tijdsspanne: Duration of the study (12 months)
The overall intervention adherence rate for all patients referred to escalated care.
Duration of the study (12 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shengjing Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 februari 2026

Primaire voltooiing (Geschat)

30 augustus 2026

Studie voltooiing (Geschat)

24 februari 2027

Studieregistratiedata

Eerst ingediend

23 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

23 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SH-CMU-SLD-Intervention

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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