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Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.

NCT03979053 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2020-01-14

No results posted yet for this study

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.

Conditions

  • Autoimmune Hepatitis

Interventions

DEVICE

Multiparametric MRI Scan

Patients attending the clinic will have a MRI scan added to their standard of care.

Sponsors & Collaborators

Principal Investigators

  • Rajarshi Banerjee, MD,PhD · Perspectum

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2019-10-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03979053 on ClinicalTrials.gov