Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT04591106
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Week
Maximum Age:
40 Years
Study:
NCT04591106
Study Brief:
Protocol Section:
NCT04591106