NCT04591106Completed
Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 135 (actual)
- First submitted
- 13 Oct 2020
- Start date
- 17 Feb 2021
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04591106
What you commit to
- Study type: Observational
- Participants enrolled: 135
- From 17 Feb 2021 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- known liver disease (except for NAFLD/NASH for the NAFLD cohort)
- known liver disease and/or infection, major congenital anomalies, inborn error of metabolism
Other
- congenital malformation
- inborn error of metabolism
- contraindications to MRI
- inability to perform breath-holding
- Study 2 (Aim 3):
- contra-indications to MRI/MRE
- inability to perform breath-holding
- Study 3 (Aim 4):
- any contraindications for an MRI exam
Who the study is looking for
- 6-17 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
- 6-17 years of age
- body mass index \<85th percentile
- ability to follow instructions and perform short breath holds
- children and adults 1 month-40 years of age
- liver disease and suspected or confirmed fibrosis
- clinically ordered liver biopsy
- Liver diseases include NAFLD/NASH, viral/medication induced hepatitis, autoimmune sclerosing cholangitis, intestinal failure associated liver disease, idiopathic hepatitis, Wilson's disease, hemosiderosis, liver rejection, and metabolic/genetic disorders
- A liver biopsy must be planned/anticipated, performed, or scheduled to be performed within ±6 months of the MRI/MRE for this study
- 1 week-6 months of age
- greater than or equal to 35 weeks gestational age
- born to a mother with gestational diabetes and whose pre-pregnancy body mass index \>=25 kg/m2
- mother must provide consent to participate in the study
- 1 week-6 months of age
- greater than or equal to 35 weeks gestational age
- appropriate for gestational age birth weight
- born to a mother with a pre-pregnancy body mass index \<25 kg/m2 and without any major co-morbid conditions (gestational diabetes, pregnancy-induced hypertension, etc.)
- admitted to the newborn nursery after birth
- mother must provide consent to participate in the study
Criteria the registry did not label
- Inclusion and Exclusion Criteria
- Study 1 (Aim 1 and Aim 2):
Age in the registry: 1 week to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.