Patient friendly liver fat measurements (CAP) in children with obesity compared with MRI-determined liver fat percentage.
- Conditions
- on-Alcoholic Steatohepatitis (NASH), Non-Alcoholic Fatty Liver Disease (NAFLD), Obesity, Paediatrics, Hepatic Steatosis, FibroScan, 1H-MR Spectroscopy Proton Density Fat Fraction (MRS-PDFF)
- Registration Number
- NL-OMON28273
- Lead Sponsor
- Amsterdam UMC, location AMC, Department of Radiology & Nuclear Medicine
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Written informed consent from parent(s) and subject (when >12 years of age)
- For current patients:
• Clinically suspected or high risk profile of hepatic steatosis based on at least one of the following:
- abnormal echogenicity of liver in ultrasonography;
- elevated serum transaminases levels;
- high BMI (>+3 z-score) and/or waist circumference (>95 percentile);
- insulin resistance.
- For patients no longer in active follow-up:
• Liver steatosis detected during follow-up in this clinic in the last 3 years
- Age <8 and >18 years
- The need for anaesthesia during the MRI examination.
- General contra-indications for MRI scanning (use of MRI checklist, see document E4)
- Known focal liver lesion(s) in the right liver lobe (proven with histology results or imaging)
- Known concomitant liver disorders
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracies of CAP and US for the detection of hepatic steatosis using 1H-MR Spectroscopy derived proton density fat fraction (MRS-PDFF) as reference standard.
- Secondary Outcome Measures
Name Time Method 1. Inter- and intraobserver variability for CAP-values;<br>2. Success rate of CAP-measurements;<br>3. Correlation between CAP-values and fat percentage at MRI-based liver fatmaps.<br>