Quantitative MRI in AIH
Research type
Research Study
Full title
Quantitative MRI to Aid Clinical Decision Making in Autoimmune Hepatitis
IRAS ID
260298
Contact name
Rajarshi Banerjee
Contact email
Sponsor organisation
Perspectum Diagnostics
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
This will be a prospective, observational, cross-sectional study designed to assess how a quantitative MRI scan will aid in a physicians' clinical decision making process in patients with suspected or confirmed autoimmune hepatitis (AIH). Participants will be recruited from the specialist outpatient hepatology clinic at Kings College Hospital NHS Trust who are either being seen as a new or follow-up patient.
Participants will be treated and assessed in line with the normal clinical care pathway.
Autoimmune hepatitis is relatively rare, with a prevalence of about 8,000 people in the UK diagnosed. It is a non-resolving liver condition that is usually treated with a combination of corticosteroid and immunosuppressant therapy. The current standard for effective management requires close monitoring of disease activity to balance disease control and unwanted side effects of treatment. The recommended management involves monthly blood tests and annual liver biopsies to verify histological remission. However, blood tests lack sensitivity and biopsy is very invasive and samples only a small portion of the liver. Indeed, liver biopsy remains the gold standard for evaluating liver pathology, however it is not appropriate for longitudinal monitoring due to pain, risk and invasiveness. Blood tests can identify when the liver is inflamed, but are insensitive to small changes and are not prognostic. There is a significant unmet need in this patient group relating to both disease monitoring and identifying those needing higher immunosuppression or transplant.
Non-invasive, quantitative MRI can characterise liver tissue to aid in the diagnosis of liver disorders. Using quantitative MRI in the management of AIH patients could be an invaluable asset within the standard care pathway to ensure more appropriate and accurate dosing of steroids is used in AIH patients, thus preventing liver failure.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0111
Date of REC Opinion
23 Apr 2019
REC opinion
Further Information Favourable Opinion