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

NCT03198104 | Completed

• 1 other identifier: PJM076
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Multiparametric MR Imaging; Paediatric

Outcome Measures

Primary Outcomes (1)

• 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.

  30 months

Secondary Outcomes (1)

• Determining use of MRI in measuring changes in liver disease within patient.

  30 months

Study Arms (3)

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

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

Healthy Volunteers

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

Device: MRI

Interventions

MRI DEVICE

Also known as: LiverMultiScan

Autoimmune Hepatitis Group (AIH); Healthy Volunteers; Liver disease

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Perspectum: lead
• Children's Memorial Health Institute, Poland: collaborator

Study Sites (1)

Children's Memorial Health Institute Poland

Warsaw, 04-730, Poland

Location

Related Publications (1)

• 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.

  PMID: 32925554 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Liver biopsy and histology.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Liver Cirrhosis; Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Chronic; Hepatitis; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rajashi Banerjee, MD, PhD

  Perspectum Diagnostics

  STUDY DIRECTOR

• Piotr Socha, MD

  Children's Memorial Health Institute, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 23, 2017
• Study Start: April 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 31, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)