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:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT03198104
Eligibility Criteria:
Inclusion Criteria:
Group 1 (Liver disease):
* Male or female between 6 - 18 years of age
* Male or female aged between 1-10 years of age and scheduled to receive an MRI under anesthesia as part of their standard care.
* Scheduled to receive an ultra-sound guided liver biopsy as part of their usual care
* Participant and guardian are willing and able to give assent and consent for participation in the study
Group 2 (AIH):
* Male or female between 6 - 18 years of age
* Male or female aged between 1-10 years of age and scheduled to receive an MRI under anesthesia as part of their standard care.
* Diagnosed with autoimmune hepatitis and due to begin liver-biopsy monitored treatment as part of their usual care
* Participant and guardian are willing and able to give assent and consent for participation in the study
Group 3 (Healthy controls):
* Male or female between 6 - 18 years of age (age-matched with Group 1)
* Lean, defined as within interquartile range for age and sex-matched childhood BMI growth charts
* Healthy, with no active medical condition requiring treatment, including diabetes, hypertension, psoriasis and any chronic gastrointestinal disorder
* Participant and guardian are willing and able to give assent and consent for participation in the study
Exclusion Criteria:
* The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT03198104
Study Brief:
Protocol Section:
NCT03198104