Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI

NCT ID: NCT03198104

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2019-03-31

Brief Summary

This is a prospective observational study which will recruit up to 100 paediatric participants over a period of 30 months to determine whether MRI is as accurate at detecting, distinguishing, and monitoring liver disease as current standard of care techniques such as liver biopsy and fibroscan.

Detailed Description

The most serious pandemic facing Europe is fatty liver disease and non-alcoholic steatohepatitis (NASH). The main causal factor is obesity: according to recent statistics 11.8m-16.3m European children are overweight, of which 2.9m - 4.4m are obese. Unfortunately, current techniques for the diagnosis and monitoring of liver disease in children are poor. Available methods are either insensitive, such as blood tests, or invasive, i.e. liver biopsy, which is risky, painful, and costly. Although it is currently considered to be the gold standard for tissue assessment, liver biopsy has severe limitations, one of which is that it samples only a tiny fraction of the liver, and so it cannot give a representative diagnosis when liver disease is regional. Early determination of liver diseases in children, could have a significant impact on changing the course of illness and on the proper treatment management.

Perspectum Diagnostics have demonstrated that multiparametric MR imaging can, for the first time, allow accurate, non-invasive detection of liver fibrosis/inflammation in adults, and predict clinical outcomes (1,2). However, liver disease in children differs from adults in aetiology, natural history and pathological findings (3,4).

This study will investigate whether non-invasive multiparametric MR imaging of the liver can accurately and reproducibly detect, distinguish and track progression of different forms of liver disease in the paediatric population. To achieve this, children with liver disease who are scheduled to undergo liver biopsy and blood tests as part of their standard care will be recruited. Non-invasive, pain-free MRI scanning will be used to measure fibrosis, iron content and fat content of liver tissue and compare these results to the findings of the liver biopsy that is being performed as standard care. Children who are scheduled to receive repeated liver biopsies to monitor their response to the treatment of autoimmune hepatitis as part of their usual care will also be included. Repeated MRI scans will be performed and compared with the results of biopsy findings.

Conditions

Non-alcoholic Steatohepatitis; Liver Diseases; Liver Fibroses; Autoimmune Hepatitis; Liver Cirrhoses

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Liver disease

Paediatric patients (50-60 pts.) with liver disease who are scheduled for an ultrasound-guided liver biopsy as part of their standard care - these patients will be scanned using MRI and fibroscan, then will proceed through standard care pathway to receive blood tests and a liver biopsy. Findings from the fibroscan, blood tests and liver biopsy will be compared to the MRI data to determine it's accuracy in detecting and distinguishing different types of liver disease.

MRI

Intervention Type: DEVICE

Autoimmune Hepatitis Group (AIH)

Paediatric patients who have been diagnosed with autoimmune hepatitis and are about to initiate pharmacological treatment (15-30 pts.) will be scanned using MRI and fibroscan, then proceed through the standard care pathway to receive repeated blood tests and liver biopsies throughout treatment. MRI and fibroscan will be repeated before each liver biopsy. Findings from the fibroscan, blood tests and liver biopsy will be compared to MRI data to determine it's accuracy in monitoring liver disease.

MRI

Intervention Type: DEVICE

Healthy Volunteers

Healthy volunteers (20-30 children) will be scanned using MRI and fibroscan and used as healthy controls.

MRI

Intervention Type: DEVICE

Interventions

MRI

Intervention Type: DEVICE

Other Intervention Names

LiverMultiScan

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Memorial Health Institute, Poland

OTHER

Sponsor Role: collaborator

Perspectum

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajashi Banerjee, MD, PhD

Role: STUDY_DIRECTOR

Perspectum Diagnostics

Piotr Socha, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Memorial Health Institute, Poland

Locations

Children's Memorial Health Institute Poland

Warsaw, , Poland

Countries

Poland

References

Janowski K, Shumbayawonda E, Dennis A, Kelly M, Bachtiar V, DeBrota D, Langford C, Thomaides-Brears H, Pronicki M, Grajkowska W, Wozniak M, Pawliszak P, Chelstowska S, Jurkiewicz E, Banerjee R, Socha P. Multiparametric MRI as a Noninvasive Monitoring Tool for Children With Autoimmune Hepatitis. J Pediatr Gastroenterol Nutr. 2021 Jan 1;72(1):108-114. doi: 10.1097/MPG.0000000000002930.

Reference Type: DERIVED

PMID: 32925554 (View on PubMed)

Other Identifiers

PJM076

Identifier Type: -

Identifier Source: org_study_id