Non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatosis hepatitis (NASH)
Conditions
Interventions
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Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.Subjects aged 6 to 18 years (>= 6 & = 85th percentile); 4.Diagnosed with Type II diabetes per standard clinical guidelines; 5.Diagnosed with hypercholesterolemia per standard clinical guidelines; 6.Confirmed or clinically suspected non-alcoholic fatty liver disease/non-alcoholic steatohepatitis based on previous medical history, imaging studies, liver biopsy, and/or laboratory tests.
Exclusion criteria
Exclusion criteria: 1.Evidence of hepatotoxicity in the clinical judgment of the investigator; 2.History of chronic liver disease (e.g., viral hepatitis, cholestatic hepatitis, or autoimmune liver disease); 3.Use of drugs associated with hepatic steatosis1: amiodarone, aethotrexate, nucleoside reverse transcriptase inhibitors (didanosine, stavudine), valproic acid, dexamethasone, tamoxifen (tamoxifen), 5-FU-based adjuvant chemotherapy, apo-B inhibitors (mipomersen, lomitapide), tetracycline exceeding 2 g/day and acetylsalicylic acid exceeding 150 mg/kg; Note: patients taking tetracycline <= 2 g/day, acetylsalicylic acid <=150 mg/kg are allowed to be enrolled; 4.Subjects with hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition; 5.Subjects anticipated or planned to undergo any therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content (e.g., bariatric surgery, chemotherapy); 6.History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or magnetic resonance imaging image quality or the subjects eligibility to undergo ultrasound or magnetic resonance imaging; 7.Subjects with unstable clinical status, late stages of a given disease, or unpredictable clinical course of a given disease; 8.Subjects have COVID-19 or judge to be at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepato-renal ratio;Acoustic attenuation (dB/cm/MHz);Tissue stiffness (kPa);sensitivity;specificity;??? Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences between operators on the same day;Data acquisition failure rate; | — |
Countries
China
Contacts
Public ContactChen Yaqing
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed