- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03198104
Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI (Kids4LIFe)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Warsaw, Poland, 04-730
- Children's Memorial Health Institute Poland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Other Names:
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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.
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Other Names:
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Healthy Volunteers
Healthy volunteers (20-30 children) will be scanned using MRI and fibroscan and used as healthy controls.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multiparametric non-invasive MRI of liver tissue in detecting and distinguishing different forms of paediatric liver disease.
Time Frame: 30 months
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Measurements using multiparametric MRI and comparison of these results with liver biopsy findings.
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30 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determining use of MRI in measuring changes in liver disease within patient.
Time Frame: 30 months
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Measurements using repeated MRI and comparison of these results with repeated paediatric liver biopsy findings throughout the course of treatment for autoimmune hepatitis.
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30 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Rajashi Banerjee, MD, PhD, Perspectum Diagnostics
- Principal Investigator: Piotr Socha, MD, Children's Memorial Health Institute, Poland
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PJM076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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