Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Control Intervention1: Ultrasound report and MRI report are the comparator: The findings on the ultrasound parameters would be compared by that of MRI findings. The ultrasound procedure time is 15 min
Sponsors
Samsung Medison Co.Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who clinically suspected MASLD based on EASL–EASD–EASO Clinical Practice Guidelines for the management of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), or patients who recommended to undergo either abdominal ultrasound examination or liver MRI examination 2. Male or Female of Age =18 years , 3. Individuals who have decided to participate in the clinical study on their own will and have provided the informed consent after reading/hearing and fully understanding the detailed explanations regarding the clinical study.
Exclusion criteria
Exclusion criteria: 1. Subject who has disagreed the signing of informed consent form for this study 2. Subject who has a history of chronic liver disease due to etiology other than MASLD. 3. Subject who had a daily alcohol consumption ?30 g for men and ?20 g for women based on EASL– ASD–EASO Clinical Practice Guidelines for the management of metabolic dysfunction associated steatotic liver disease (MASLD) 4. Subject who has a history of long-term use of hepatotoxic drugs. 5. Subject with acute liver failure 6. Subject who has a history of esophageal varix, hydrops abdominis, hepatic coma, as well as patents with signs of acute biliary obstruction, or those who had recent liver surgery. 7. Woman who is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the diagnostic accuracy of TAI, TSI and US Fat fraction to predict different grades of hepatic steatosis in comparison with MRI-PDFF;S2 and S3Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, Specificity, Positive predictive value (PPV), Negative Predictive Value (NPV) and accuracy of quantitative ultrasound imaging parameters according to hepatic steatosis grade (S2, S3) ? Optimal cut-off value of each of the three parameters in predicting non-alcoholic fatty liver according to hepatic steatosis grade (S2, S3) for patients with suspected non-alcoholic fatty liver ? The correlation between USFF and MRI-PDFF for assessing hepatic steatosis ? The correlation between TAITM and MRI-PDFF for assessing hepatic steatosis. ? The difference of diagnostic performance of USFF in compared to the subject assessment of B-mode in each steatosis grade ? Bias, defined as the average difference between MRI-PDFF and USFF measurements per participantTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactMuskan Arora
Max Smart Super speciality Hospital
Outcome results
None listed