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Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE

NCT04591106 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2026-03-10

No results posted yet for this study

Summary

Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness. The information from MRI and MRE are used to understand risk factors and diagnose liver diseases, such as fatty liver disease and liver fibrosis. However, current MRI and MRE scans need to be performed during a breath-hold, which may be challenging or impossible in children and infants. The goal of this research project is to develop and evaluate new free-breathing MRI and MRE technology to improve the comfort and diagnostic accuracy for children and infants.

Conditions

  • NAFLD
  • NASH - Nonalcoholic Steatohepatitis

Interventions

DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI)

Magnetic resonance imaging (MRI) is a non-invasive imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body.

DIAGNOSTIC_TEST

Magnetic resonance elastography (MRE)

Magnetic resonance elastography (MRE) is a non-invasive imaging technique that uses a gently vibrating transducer in combination with MRI to create detailed images and maps of the mechanical properties, such as stiffness, of tissues within the body.

DEVICE

Prototype MRE soft flexible passive transducer paddle

The prototype device is provided to the investigators by Mayo Clinic under a Materials Transfer Agreement (MTA). The device is being used to promote comfort in the pediatric population; no formal data collection for regulatory submission is planned. The prototype device is smaller, softer, and more flexible than the commercial device and will be used where indicated by the subjects' size.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of California, Los Angeles

    lead OTHER

Eligibility

Min Age
1 Week
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2026-02-28
Completion
2026-02-28
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 NCT04591106 on ClinicalTrials.gov