ST-AI: Observational and Prospective Study of Hepatic Steatosis and Related Risk Factors Using Ultrasound and Artificial Intelligence

Sponsor
University of Bari (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06103175
Collaborator
Eurisko Technology srl (Other), Centro Radiologico Lucano (Other)
150
1
21.6
7

Study Details

Study Description

Brief Summary

Fatty liver is the most frequent chronic liver disease worldwide and ultrasonography is widely employed for diagnosis. The accuracy of this technique, however, is strongly operator-dependent. Few information is available, so far, on the possible use of algorithms based on Articifial Intelligence (AI) to ameliorate the diagnostic accuracy of ultrasonography in diagnosing fatty liver. This study showed that the use of AI is able to improve the diagnostic accuracy of ultrasonography in the diagnosis of fatty liver

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In recent years, ultrasound has taken on a predominant role in the evaluation of liver steatosis, as it is a non-invasive, non-irradiating method that is easily reproducible and inexpensive. Of particular effectiveness is the use of the hepatorenal index, evaluated as the intensity ratio (echogenicity) between the hepatic parenchyma and the renal cortical parenchyma. The main limitations of detecting the hepato-renal index during abdominal ultrasound, however, are operator dependence and the use of a relatively long time span to complete the sequence of operations and calculations required to determine the index itself. The use of Artificial Intelligence (AI) techniques for image analysis in the medical field is yielding excellent results. AI-based algorithms are increasingly a powerful tool that allows the physician to improve their performance in terms of speed and accuracy of clinical evaluations. Today, there is already evidence of the effectiveness of using AI on ultrasound images for clinical evaluations. The use of AI as an aid in diagnosing liver diseases through ultrasound is still under-researched. The hypothesis to be tested is the utility that AI can have in the evaluation, its general and specific uses in reducing calculation times of the hepatorenal index.

    In this study, 134 patients were enrolled with no clinical suspicion of liver steatosis. All patients underwent abdominal ultrasonography (US) and magnetic resonance imaging fat fraction (MRI-PDFF), assumed as reference technique to evaluate the grade of steatosis. The hepatorenal index (US) was manually calculated (HRIM) by 4 skilled operators. An automatic hepatorenal index calculation (HRIA) was also obtained by an algorithm. The accuracy of HRIA to discriminate different grades of fatty liver was evaluated by ROC analysis using MRI-PDFF cut-offs.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Observational and Prospective Study of Hepatic Steatosis and Related Risk Factors Using Ultrasound and Artificial Intelligence
    Actual Study Start Date :
    Jan 15, 2023
    Actual Primary Completion Date :
    Jun 15, 2023
    Anticipated Study Completion Date :
    Nov 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Hepato-renal index calculation [4 months]

      Calculation of the Hepatorenal Index manually and automatically using the AI-based algorithm.

    2. Magnetic Resonance scanning and fat percentage evaluation [4 months]

      Proton Density Fat Fraction MRI scans (MRI-PDFF) to evaluate the liver fat percentage as the average value of percentage of fat evaluated for each liver segment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age between 18-70 years

    • MRI regardless of clinical indications,

    • written informed consent

    Exclusion Criteria:
    • cirrhosis

    • hepatocellular carcinoma or any liver tumours,

    • absence of the right kidney

    • previous liver transplantation

    • large liver cysts or kidney cysts

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Department of Precision and Regenerative Medicine and Ionian Area (DiMePre-J - Clinica medica "A. Murri" Bari BA Italy 70124

    Sponsors and Collaborators

    • University of Bari
    • Eurisko Technology srl
    • Centro Radiologico Lucano

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    piero portincasa, Professor, MD, University of Bari
    ClinicalTrials.gov Identifier:
    NCT06103175
    Other Study ID Numbers:
    • AI-steatosis
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2023