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An Imaging-based Quantitative Biomarker Assay for NAFLD in Children

NCT ID: NCT06354491

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2028-07-01

Brief Summary

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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

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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.

Conditions

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NAFLD NASH

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Average or low BMI

Children with BMI under the 85th percentile for age and sex

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

MRI procedures will include a 20-25 minute exam with periodic breath holds. The imaging series will be conducted twice to assess repeatability.

Ultrasound (US)

Intervention Type DEVICE

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.

High BMI

Children with BMI in the 95th percentile or higher for age and sex

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

MRI procedures will include a 20-25 minute exam with periodic breath holds. The imaging series will be conducted twice to assess repeatability.

Ultrasound (US)

Intervention Type DEVICE

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.

Interventions

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Magnetic Resonance Imaging (MRI)

MRI procedures will include a 20-25 minute exam with periodic breath holds. The imaging series will be conducted twice to assess repeatability.

Intervention Type DEVICE

Ultrasound (US)

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivan Rosado-Mendez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Diego Hernando, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin, Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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A534800

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 12/19/24

Identifier Type: OTHER

Identifier Source: secondary_id

2023-1494

Identifier Type: -

Identifier Source: org_study_id