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Patient friendly liver fat measurements (CAP) in obese children compared with MRI-determined liver fat percentage.


- candidate number16125
- NTR NumberNTR4345
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2014
- Secondary IDsNL47936.018.14 
- Public TitlePatient friendly liver fat measurements (CAP) in obese children compared with MRI-determined liver fat percentage.
- Scientific TitleEvaluation of the CAP-value for quantitating liver steatosis in obese children using 1H-MRS as reference standard.
- ACRONYMCAPped
- hypothesisHepatic steatosis is becoming a large health burden in both Western and non-Western societies. In children, the trend of increasing obesity means more and more children are at risk of developing liver steatosis. As liver steatosis is a risk factor in the development of diabetes mellitus type 2 and cardio-vascular disease, there is a need for specific diagnostic tools that can identify the children with liver steatosis and if possible, quantify the amount of steatosis. Quantification will help clinicians to guide therapy. Several tools exist, such as ultrasonography, CT, serum test panels, MR Imaging, 1H-MR Spectroscopy and liver biopsy. However, all suffer from shortcomings. A new tool for quantifying steatosis is the Controlled Attenuation Parameter (CAP), available on the FibroScan (a device used to determine the presence of liver fibrosis). This tool has been investigated in adults thus far and has only been compared to the results of liver biopsy, a semi-quantitative score. In this study we will investigate our hypothesis that the Fibroscan/CAP can be used in obese children to identify those with steatosis and obtain a quantitative measure of the amount of liver fat.
- Healt Condition(s) or Problem(s) studiedNon alcoholic steato hepatitis (NASH), Obesity, Hepatic steatosis, FibroScan, Non-Alcoholic Fatty Liver Disease (NAFLD)
- Inclusion criteria- 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
- Exclusion criteria- 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate27-feb-2015
- Target number of participants25
- InterventionsN/A
- Primary outcomeCorrelation between CAP-values and fat percentage found at 1H-MR Spectroscopy of the right liver lobe (segment VI or VII).
- Secondary outcome1. Inter- and intraobserver variability for CAP-values; 2. Success rate of CAP-measurements; 3. Correlation between TE-values and liver stiffness values found at MRE; 4. Correlation between CAP-values and fat percentage at MRI-based liver fatmaps.
- Timepoints1. CAP-value measured with FibroScan device (once by examiner 1, twice by examiner 2) at visit 1. 2. Liver fat fraction and Elastography-values measured with MRI at visit 1.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Jurgen Runge
- CONTACT for SCIENTIFIC QUERIESProf. dr. J. Stoker
- Sponsor/Initiator Academic Medical Center (AMC), Department of Radiology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Radiology
- PublicationsN/A
- Brief summaryCAPped is a study in which the CAP-measurement of liver fat content is validated in an overweight or obese paediatric population in the Netherlands. The CAP-value is compared to MRI-determined liver fat fractions. 25 subjects will be included and receive both CAP-measurement and a MRI-scan on one day. All subjects are recruited in the Netherlands (in the AMC ).
- Main changes (audit trail)
- RECORD21-jan-2014 - 21-jan-2014


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