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Search / Trial NCT04591106

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

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Oct 15, 2020

Trial Information

Current as of July 26, 2025

Enrolling by invitation

Keywords

Mri Pediatric Liver Fibrosis

ClinConnect Summary

More than 13.7 million children in the U.S. are obese, and all are at high risk for non-alcoholic fatty liver disease (NAFLD), which can lead to fibrosis and progress to liver failure. NAFLD is the most common chronic pediatric liver disease and number one indication for liver transplant in young adults. Accurate assessments of visceral adipose tissue and hepatic fat and fibrosis are critical to the understanding, early diagnosis, and evaluation of new treatments for pediatric obesity and NAFLD. However, there is a lack of child-appropriate technologies to quantify visceral adipose tissue a...

Gender

ALL

Eligibility criteria

  • Inclusion and Exclusion Criteria
  • Study 1 (Aim 1 and Aim 2):
  • Inclusion criteria for the NAFLD cohort:
  • 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
  • Inclusion criteria for the healthy cohort:
  • 6-17 years of age
  • body mass index \<85th percentile
  • ability to follow instructions and perform short breath holds
  • Exclusion criteria for both cohorts:
  • 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):
  • Inclusion criteria:
  • 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
  • Exclusion Criteria:
  • contra-indications to MRI/MRE
  • inability to perform breath-holding
  • Study 3 (Aim 4):
  • Inclusion criteria for the cohort of infants at risk for future obesity and NAFLD:
  • 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
  • Inclusion criteria for the healthy cohort:
  • 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
  • Exclusion criteria for both cohorts:
  • known liver disease and/or infection, major congenital anomalies, inborn error of metabolism
  • any contraindications for an MRI exam

About University Of California, Los Angeles

The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.

Locations

Los Angeles, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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