An Imaging-based Quantitative Biomarker Assay for NAFLD in Children

NCT06354491 | Active Not Recruiting FDA Device

• 3 other identifiers: 2023-1494A534800Protocol Version 12/19/24
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

NAFLD; NASH

Outcome Measures

Primary Outcomes (1)

• Feasibility Measured by the Number of Participants Who Successfully Complete the Interventions

  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.

  through study enrollment (up to approximately 14 months)

Secondary Outcomes (6)

• MRI: Bias reported as difference in mean error in Percent Liver Fat measured from free-breathing MRI method and reference breath-held MRI method

  Research visit 1 (up to 14 months)

• MRI: Precision measured by Test-Retest of Percent Liver Fat

  Research visit 1 (up to 14 months)

• Quantitative US: Repeatability of US Measurements (same sonographer) - Attenuation Coefficient (dB/cm-MHz)

  Research visit 1 (up to 14 months)

• Quantitative US: Repeatability of US Measurements (same sonographer) - Backscatter Coefficient (1/cm*sr)

  Research visit 1 (up to 14 months)

• Quantitative US: Reproducibility of US Measurements (different sonographers) - Attenuation Coefficient (dB/cm-MHz)

  Research visit 1 (up to 14 months)

Study Arms (2)

Average or low BMI

EXPERIMENTAL

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

Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound (US)

High BMI

EXPERIMENTAL

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

Device: Magnetic Resonance Imaging (MRI); Device: Ultrasound (US)

Interventions

Magnetic Resonance Imaging (MRI) DEVICE

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

Average or low BMI; High BMI

Ultrasound (US) 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.

Average or low BMI; High BMI

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Magnetic Resonance Imaging; Ultrasonography

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ivan Rosado-Mendez, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Diego Hernando, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: April 1, 2024
• Primary Completion: June 20, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)