Non-alcoholic SteatohepatitisKids4LIFeNCT03198104
Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI
An observational study of Non-alcoholic Steatohepatitis and Liver Diseases, run by Perspectum at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Liver Diseases, Liver Fibroses
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2016to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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):
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- MRI
- Keywords
- Multiparametric MR Imaging, Paediatric
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases, Liver Cirrhosis, Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called LiverMultiScan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI | |
| 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. Receives: Device: MRI | |
| Healthy Volunteers | Healthy volunteers (20-30 children) will be scanned using MRI and fibroscan and used as healthy controls. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiparametric non-invasive MRI of liver tissue in detecting and distinguishing different forms of paediatric liver disease.
Measurements using multiparametric MRI and comparison of these results with liver biopsy findings.
Measured: 30 months
Secondary outcomes (1)
Determining use of MRI in measuring changes in liver disease within patient.
Measurements using repeated MRI and comparison of these results with repeated paediatric liver biopsy findings throughout the course of treatment for autoimmune hepatitis.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Apr 2016
- Primary completion1 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Memorial Health Institute, Poland
- Responsible party
- Sponsor
- Investigators
- Rajashi Banerjee, MD, PhD, Study director, Perspectum DiagnosticsPiotr Socha, MD, Principal investigator, Children's Memorial Health Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198104
- Sponsor's protocol ID
- PJM076
- Acronym
- Kids4LIFe
- Status last verified
- Aug 2019
- First submitted
- 19 Jun 2017
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Publications
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.
PubMed 32925554
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI
- ClinicalTrials.gov ID
- NCT03198104
- Acronym / sponsor ID
- Kids4LIFe / PJM076
- Conditions
- Non-alcoholic Steatohepatitis, Liver Diseases, Liver Fibroses, Autoimmune Hepatitis, Liver Cirrhoses
- Keywords
- Multiparametric MR Imaging, Paediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Collaborators
- Children's Memorial Health Institute, Poland
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liver disease | – | Device: MRIPaediatric 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. |
| Autoimmune Hepatitis Group (AIH) | – | Device: MRIPaediatric 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. |
| Healthy Volunteers | – | Device: MRIHealthy volunteers (20-30 children) will be scanned using MRI and fibroscan and used as healthy controls. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (15 listed)
- 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
- Male or female between 6 - 18 years of age
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: LiverMultiScan | Device | Autoimmune Hepatitis Group (AIH), Healthy Volunteers, Liver disease |
Primary outcome
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.
1 secondary outcome
Determining use of MRI in measuring changes in liver disease within patient.
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Derived from this study: PubMed 32925554Janowski 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajashi Banerjee, MD, PhD study director
Perspectum Diagnostics
Piotr Socha, MD principal investigator
Children's Memorial Health Institute, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Steatohepatitis and Liver Diseases, run by Perspectum at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiparametric non-invasive MRI of liver tissue in detecting and distinguishing different forms of paediatric liver disease. (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.