Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE
2 other identifiers
observational
135
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
February 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMarch 10, 2026
March 1, 2026
5 years
October 13, 2020
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Liver Proton Density Fat Fraction (PDFF) by MRI
Liver proton density fat fraction (PDFF; 0 to 100%) is an MRI based measurement of liver fat content. The liver PDFF measured by the new free-breathing MRI technique will be compared with standard breath-holding MRI in terms of the concordance correlation coefficient. The repeatability of liver PDFF will be measured in terms of the coefficient of variation between two scans. In addition, the diagnostic performance of MRI liver PDFF to detect liver fat will be validated against liver biopsy.
4 years
Abdominal Visceral Adipose Tissue (VAT) Volume by MRI
Visceral adipose tissue (VAT) volume (cm3) in the abdomen is an MRI based measurement of body composition. The VAT volume measured by the new free-breathing MRI technique will be compared with standard breath-holding MRI in terms of the concordance correlation coefficient. The repeatability of VAT volume will be measured in terms of the coefficient of variation between two scans.
4 years
Liver Tissue Stiffness by MRE
Liver tissue stiffness (kPa) measured by MRE correlates with liver fibrosis. The liver tissue stiffness measured by the new free-breathing MRE technique will be compared with standard breath-holding MRE in terms of the concordance correlation coefficient. The repeatability of liver tissue stiffness will be measured in terms of the coefficient of variation between two scans. In addition, the diagnostic performance of MRE liver tissue stiffness to detect liver fibrosis will be validated against liver biopsy.
4 years
Study Arms (3)
Group 1
50 healthy subjects and 50 subjects with NAFLD between ages of 6-17 years old. Each subject will receive 1 MRI/MRE exam. The MRE portion will be performed by placing a paddle on the belly that will produce gentle vibrations.
Group 2
60 subjects with Liver Disease and Fibrosis between ages of 1 month - 40 years old. Each subject will receive 1 MRI/MRE exam. The MRE portion will be performed by placing a paddle on the belly that will produce gentle vibrations.
Group 3
15 healthy infants between 1 week - 6 months old and their mothers; 15 at-risk infants (mother had gestational diabetes) between 1 week - 6 months old and their mothers. Each infant will receive 1 MRI scan.
Interventions
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.
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.
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.
Eligibility Criteria
Study 1 (Aim 1 and Aim 2): 50 healthy subjects 6-17 years old, 50 subjects with NAFLD 6-17 years old; Study 2 (Aim 3): 60 subjects with Liver Disease and Fibrosis 1 month-40 years old; Study 3 (Aim 4): Study 3 (Aim 4): 15 Pairs of Healthy Infants (1 week-6 months old) and their Mothers. 15 Pairs of Infants (1 week-6 months old) born to Mothers with Gestational Diabetes and their Mothers.
You may not qualify if:
- Study 1 (Aim 1 and Aim 2):
- years of age
- BMI \>85th percentile
- diagnosed or clinically suspected to have NAFLD (NAFLD or suspected NAFLD is defined as serum alanine transaminase concentration \>30 IU/L in the appropriate clinical setting)
- ability to follow instructions and perform short breath holds
- years of age
- body mass index \<85th percentile
- ability to follow instructions and perform short breath holds
- known liver disease (except for NAFLD/NASH for the NAFLD cohort)
- congenital malformation
- inborn error of metabolism
- contraindications to MRI
- inability to perform breath-holding
- Study 2 (Aim 3):
- children and adults 1 month-40 years of age
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA Medical Center
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 13, 2020
First Posted
October 19, 2020
Study Start
February 17, 2021
Primary Completion
February 28, 2026
Study Completion
February 28, 2026
Last Updated
March 10, 2026
Record last verified: 2026-03