University of Wisconsin, Madison
Madison, Wisconsin, 53705, United States
NCT Number: NCT06354491
This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI).
This study is active but is not currently recruiting participants.
10 year–14 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
The severity of the obesity epidemic in the U.S., particularly in Wisconsin, is alarming, with overall overweight or obesity rates of 35% in children. [Fryar 2020,] Obesity is a major risk factor for several comorbidities, one of the most common being non-alcoholic fatty liver disease (NAFLD, also denoted steatotic liver disease). The inflammatory state known as non-alcoholic steatohepatitis (NASH) may lead to fibrosis and, if left untreated, can lead to cirrhosis, liver failure, and cancer. For these reasons, there is enormous interest in effective interventions for weight loss and reversing NAFLD. A central challenge in the development of new interventions is the need for accurate and precise biomarkers to evaluate hepatic steatosis in children.
This pilot study focuses on demonstrating the feasibility of MRI and US based liver fat quantification in children and addresses technical challenges that may limit the performance of the proposed techniques in the population of interest through the following aims:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MRI procedures will include a 20-25 minute exam with periodic breath holds. The imaging series will be conducted twice to assess repeatability.
In each ultrasound exam, each participant will be scanned by twice by the same sonographer to evaluate intra-operator variability (repeatability). Each exam will take approximately 60 minutes to complete.
Time frame: through study enrollment (up to approximately 14 months)
Demonstrate the feasibility of MRI- and US-based liver fat quantification in children and address technical challenges that may limit the performance of the proposed techniques in the population of interest.
Time frame: Research visit 1 (up to 14 months)
To validate and confirm the reliability of a recently developed free-breathing CSE-based PDFF mapping method in children with high and average/low BMI for age and sex, bias is reported. Bias is defined as the mean error in liver PDFF measurements between the new free-breathing MRI method and the reference breath-held MRI method, reported in percentage.
Time frame: Research visit 1 (up to 14 months)
To validate and confirm the reliability of a recently developed free-breathing CSE-based PDFF mapping method in children with high and average/low BMI for age and sex, precision will be assessed.
Precision (test-retest repeatability) for each acquisition method and within each liver segment will be calculated through the coefficient of repeatability.
Time frame: Research visit 1 (up to 14 months)
Biomarkers of liver steatosis are measured and analyzed for their repeatability by the same sonographer in the high and healthy BMI cohorts.
Time frame: Research visit 1 (up to 14 months)
Biomarkers of liver steatosis are measured and analyzed for their repeatability by the same sonographer in the high and healthy BMI cohorts.
Time frame: Research visit 1 (up to 14 months)
Biomarkers of liver steatosis are measured and analyzed for their reproducibility between different sonographers in the healthy BMI cohort.
Time frame: Research visit 1 (up to 14 months)
Biomarkers of liver steatosis are measured and analyzed for their reproducibility between different sonographers in the healthy BMI cohort.
University of Wisconsin, Madison
Other
An Imaging-based Quantitative Biomarker Assay for Non-alcoholic Fatty Liver Disease (NAFLD) in Children: a Feasibility Study
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