Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.
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|ClinicalTrials.gov Identifier: NCT03979053|
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : January 14, 2020
This will be a prospective, observational, cross-sectional study designed to assess how a quantitative Magnetic Resonance Imaging (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 (National Health Service) 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 United Kingdom (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 over/under treating.
|Condition or disease||Intervention/treatment|
|Autoimmune Hepatitis||Device: Multiparametric MRI Scan|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.|
|Actual Study Start Date :||June 26, 2019|
|Actual Primary Completion Date :||October 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Patients with AIH
60 adult participants will be recruited who are over the age of 18 and are attending a hepatology appointment at KCH NHS FT and are either being investigated for AIH or have confirmed AIH
Device: Multiparametric MRI Scan
Patients attending the clinic will have a MRI scan added to their standard of care.
- The effect of quantitative Magnetic Resonance Imaging (MRI) results on a physician's diagnosis and/or plans for patient with suspected or confirmed Autoimmune hepatitis (AIH) compared with usual standard of care. [ Time Frame: 1 Year ]60 patients with suspected or confirmed AIH will have a MRI scan using LiverMultiScan and the number of patients in whom diagnosis and/or intended clinical management is changed when quantitative MRI results are delivered will be compared to the standard of care.
- Cost-effectiveness of adding LiverMultiScan (LMS) to the standard of care pathway by reducing the inpatient and outpatient management costs. [ Time Frame: 1 year ]Introducing the LMS into the standard of care could potentially reduce in patient and outpatient management costs by reducing unnecessary appointments in secondary care.
- Comparing the changes in the multi-parametric Magnetic Resonance Imaging (MRI) measurements and blood bio-markers in patients with AIH. [ Time Frame: 1 year ]The Multi parametric MRI measurements including cT1 (indicates inflammation and fibrosis) T2* (indicates iron levels) and PDFF (indicates fat levels) will be compared with AIH blood bio-markers, like liver function test (LFTs), to identify whether there is correlation between MRI and AIH blood bio-markers.
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): NCT03979053
|King College Hospital|
|London, United Kingdom, SE5 9RS|
|Principal Investigator:||Rajarshi Banerjee, MD,PhD||Perspectum|