MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jun 6, 2017

Keywords

ClinConnect Summary

This clinical trial is studying how MRI scans can help predict the progression of autoimmune liver diseases, specifically in young people aged 6 to 23. Autoimmune liver diseases, like Autoimmune Hepatitis and Primary Sclerosing Cholangitis, can lead to serious liver problems in adolescents. Researchers want to see if certain MRI measurements can provide more accurate information about the disease's progression compared to standard tests. Participants will have MRI scans done at the start of the study and again after one and two years, along with ongoing clinical assessments for ten years. The findings may help doctors better understand how these diseases develop and improve patient care.

To join the study, participants must be between 6 and 23 years old and have a confirmed diagnosis of either Autoimmune Hepatitis or Primary Sclerosing Cholangitis. However, individuals with certain conditions, such as those who have had a liver transplant or have chronic hepatitis infections, cannot participate. Those who enroll can expect to have regular MRI scans and medical evaluations, which will help contribute to important research that could improve treatment and outcomes for young patients with liver disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 6-23 years old.
• • 2. Established clinical diagnosis of AIH or PSC.
• Exclusion Criteria:
• • 1. History of liver transplantation.
• • 2. Chronic Hepatitis B or untreated hepatitis C virus infection.
• • 3. Pregnancy.
• • 4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).
• • 5. Diagnosis of cystic fibrosis or biliary atresia
• • 6. Diagnosis of cardiac hepatopathy.
• • 7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.
• • 8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).