This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study.
This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study. To assess the correlation between the quantitative ultrasound biomarkers, i.e., HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI proton density fat fraction (MRI-PDFF) on pediatric patients, in order to evaluate the technical feasibility of using HRIQ, AttenQ and ElastQ to quantify liver fat content for pediatric patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
90
All subjects will undergo a 2D ultrasound scan and MRI examination.
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, China
Rate of HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI
To assess the correlation between the quantitative ultrasound biomarkers, i.e., HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI proton density fat fraction (MRI-PDFF) on pediatric patients, in order to evaluate the technical feasibility of using HRIQ, AttenQ and ElastQ to quantify liver fat content for pediatric patients.
Time frame: up to 28 months
The concentration of robustness of the investigational LFQ software in the clinical settings
To assess the inter-operator variability on the same day and the data acquisition failure rate (i.e., the percentage of the subjects whose image quality is unacceptable due to technical limitations) of these quantitative ultrasound biomarkers, in order to evaluate the robustness of the investigational LFQ software in the clinical settings.
Time frame: up to 28 months
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