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Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI (Kids4LIFe)

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ClinicalTrials.gov Identifier: NCT03198104
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
Children's Memorial Health Institute, Poland
Information provided by (Responsible Party):
Perspectum Diagnostics Ltd

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.

Condition or disease Intervention/treatment
Non-alcoholic Steatohepatitis Liver Diseases Liver Fibroses Autoimmune Hepatitis Liver Cirrhoses Device: MRI

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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


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.
Device: MRI
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.
Device: MRI
Other Name: LiverMultiScan

Healthy Volunteers
Healthy volunteers (20-30 children) will be scanned using MRI and fibroscan and used as healthy controls.
Device: MRI
Other Name: LiverMultiScan




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Liver biopsy and histology.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants aged between 6-18 years of age with liver disease who are scheduled to receive a liver biopsy as part of their usual care and age-matched healthy volunteers aged 6-18 years of age. Participants between 1-10 years of age who are scheduled to receive an MRI scan under anesthesia as part of their standard care will also be recruited.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Dan Green, PhD +44(0)1865655343 dan.green@perspectum-diagnostics.com
Contact: Velicia Bachtiar, PhD +44(0)1865655343 velicia.bachtiar@perspectum-diagnostics.com

Locations
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Poland
Children's Memorial Health Institute Poland Recruiting
Warsaw, Poland, 04-730
Principal Investigator: Piotr Socha, MD         
Sponsors and Collaborators
Perspectum Diagnostics Ltd
Children's Memorial Health Institute, Poland
Investigators
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Study Director: Rajashi Banerjee, MD, PhD Perspectum Diagnostics
Principal Investigator: Piotr Socha, MD Children's Memorial Health Institute, Poland

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Responsible Party: Perspectum Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT03198104     History of Changes
Other Study ID Numbers: PJM076
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data stored from patients (including MRI data files) will be anonymised during upload to the custom-built data management system that is being designed specifically for this study. No project partner will be able to access identifiable information (with the exception of the medical team who will upload the data).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Perspectum Diagnostics Ltd:
Multiparametric MR Imaging
Paediatric

Additional relevant MeSH terms:
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Inflammation
Fatty Liver
Non-alcoholic Fatty Liver Disease
Fibrosis
Liver Diseases
Liver Cirrhosis
Hepatitis, Autoimmune
Hepatitis
Pathologic Processes
Digestive System Diseases
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases