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

About

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.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
1 Week
Maximum Age
40 Years

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

Join this Trial

Enrolling by Invitation
These studies are not open to everyone who meets the eligibility criteria, but only to people in that particular population, who are specifically invited to participate.
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Study Stats
Protocol No.
20-000321
Category
Healthy Volunteers
Liver/Hepatic Disorders
Principal Investigator
Holden Wu
Contact
Saima Chaabane
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04591106
For detailed technical eligibility, visit ClinicalTrials.gov.