Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354491
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-03
Brief Title:
An Imaging-based Quantitative Biomarker Assay for NAFLD in Children
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
An Imaging-based Quantitative Biomarker Assay for Non-alcoholic Fatty Liver Disease NAFLD in Children a Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None