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An Imaging-based Quantitative Biomarker Assay for NAFLD in Children

NCT06354491 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Ivan Rosado-Mendez, PhD · University of Wisconsin, Madison

  • Diego Hernando, PhD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-06-20
Completion
2028-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06354491 on ClinicalTrials.gov