Clinical trial NCT06354491: An Imaging-based Quantitative Biomarker Assay for NAFLD in Children
Official title: An Imaging-based Quantitative Biomarker Assay for Non-alcoholic Fatty Liver Disease (NAFLD) in Children: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NAFLD
NASH
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. 12 Children ages 10 - 14 years with BMI in the \>95th percentile for age and sex
2. 12 Children ages 10 - 14 years with BMI \< 85th percentile and \>5th percentile for age and sex.

Brief summary: 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).

Detailed description: 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:

* Aim 1: Determine the bias and precision (repeatability) of emerging free-breathing MRI-based liver fat quantification in children with obesity and controls using current breath-held methods as a reference.
* Aim 2: Determine the precision (repeatability and reproducibility) of US-based biomarkers of liver steatosis with a focus on the impact of body wall thickness on the precision of the biomarkers.

Eligibility criteria: Inclusion Criteria:

1. Age: 10 - 14years old
2. BMI: Case subjects: BMI\>95th percentile for age and sex Healthy BMI volunteers: 5th ≤ BMI \< 85th percentile for age and sex

Exclusion Criteria:

1. Children with contraindications to MRI.
2. Children who did not fast (verbally confirmed by children or guardian)
3. Pregnant

Primary outcomes:
measure: MRI
timeFrame: Research visit 1
measure: Quantitative US
timeFrame: Research visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ivan Rosado-Mendez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Diego Hernando, PhD
role: PRINCIPAL_INVESTIGATOR
References: