Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI (Kids4LIFe)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03198104|
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment|
|Non-alcoholic Steatohepatitis Liver Diseases Liver Fibroses Autoimmune Hepatitis Liver Cirrhoses||Device: MRI|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI|
|Actual Study Start Date :||April 1, 2016|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||March 31, 2019|
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.
Other Name: LiverMultiScan
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.
Other Name: LiverMultiScan
Healthy volunteers (20-30 children) will be scanned using MRI and fibroscan and used as healthy controls.
Other Name: LiverMultiScan
- Multiparametric non-invasive MRI of liver tissue in detecting and distinguishing different forms of paediatric liver disease. [ Time Frame: 30 months ]Measurements using multiparametric MRI and comparison of these results with liver biopsy findings.
- Determining use of MRI in measuring changes in liver disease within patient. [ Time Frame: 30 months ]Measurements using repeated MRI and comparison of these results with repeated paediatric liver biopsy findings throughout the course of treatment for autoimmune hepatitis.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198104
|Contact: Dan Green, PhD||+44(0)email@example.com|
|Contact: Velicia Bachtiar, PhD||+44(0)firstname.lastname@example.org|
|Children's Memorial Health Institute Poland||Recruiting|
|Warsaw, Poland, 04-730|
|Principal Investigator: Piotr Socha, MD|
|Study Director:||Rajashi Banerjee, MD, PhD||Perspectum Diagnostics|
|Principal Investigator:||Piotr Socha, MD||Children's Memorial Health Institute, Poland|