Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Perspectum
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Detailed Description
This will be a single centre quantitative study recruiting 60 participants from those patients attending the hepatology outpatient clinic at Kings College Hospital NHS (National Health Service) Trust. It will set out to determine the impact of quantitative Magnetic Resonance Imaging (MRI) (using LiverMultiScan (LMS)) on intended patient management for Autoimmune Hepatitis (AIH) patients in comparison with the current usual standard of care. Participants will be made aware of the study by a member of clinical care team.
All participants will attend their planned outpatient hepatology appointment. The consultant will document the intended treatment plan for each participant in line with their usual care pathway. Following this, participants will be required to attend one dedicated study visit with no continued follow-up. This will involve an Magnetic Resonance Image (MRI) scan. This visit will be scheduled for the same day as their outpatient appointment, or within a 7-day window around their appointment with the consultant.
The results of this scan will be analysed, and a report securely sent to the consultant who will review participants original documented care plan alongside the LMS report. The consultant will be asked to describe any changes he would have made based on the new information that is provided by the scan. Consideration will also be taken for quantifying the potential cost-effectiveness of adding LMS to the standard care pathway.
The study Magnetic Resonance Imaging (MRI) will be conducted within a London based MRI imaging centre where LMS is installed and compatible with the allocated scanner (1.5Tesla/3Tesla).
Sample size: The primary endpoint of the study is to determine the proportion of patients for whom a change in intended treatment would occur following clinical review of LMS data.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients aged 18 years or over
- •Patient due to attend the hepatology clinic for AIH diagnostics/review
- •Participant is willing and able to give informed consent
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Comparing the changes in the multi-parametric Magnetic Resonance Imaging (MRI) measurements and blood bio-markers in patients with AIH.(1 year)
- Cost-effectiveness of adding LiverMultiScan (LMS) to the standard of care pathway by reducing the inpatient and outpatient management costs.(1 year)