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

NCT03979053 | Completed DMC FDA Device

• 1 other identifier: CA-069
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hepatitis

Keywords

Auto Immune Hepatitis, Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 Year

Secondary Outcomes (2)

• Cost-effectiveness of adding LiverMultiScan (LMS) to the standard of care pathway by reducing the inpatient and outpatient management costs.

  1 year

• Comparing the changes in the multi-parametric Magnetic Resonance Imaging (MRI) measurements and blood bio-markers in patients with AIH.

  1 year

Study Arms (1)

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

Interventions

Multiparametric MRI Scan DEVICE

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

Patients with AIH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will be 60 males and females who are 18 and over who are attending the hepatology outpatient clinic at Kings College Hospital NHS Trust. All participants will attend their planned outpatient hepatology appointment. Participants will be required to attend one dedicated study visit For the MRI scan with no continued follow-up.

You may qualify if:

• 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

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
• King's College London: collaborator

Study Sites (1)

King College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (4)

• Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12.

  PMID: 24036007 BACKGROUND

• Pavlides M, Banerjee R, Sellwood J, Kelly CJ, Robson MD, Booth JC, Collier J, Neubauer S, Barnes E. Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. J Hepatol. 2016 Feb;64(2):308-315. doi: 10.1016/j.jhep.2015.10.009. Epub 2015 Nov 10.

  PMID: 26471505 BACKGROUND

• Arndtz K, Hodson J, Eddowes P, Kelly M, Dennis A, Fiore M, et al. Cross-Sectional, Prospective, Evaluation of the Utility of Multi-Parametric MRI Imaging in Predicting Clinically Meaningful Outcomes in Autoimmune Hepatitis. Hepatology. 2018;68(1):1961

  BACKGROUND

• Bajre M, Moawad M, Shumbayawonda E, Carolan JE, Hart J, Culver E, Heneghan M. LiverMultiScan as an alternative to liver biopsy to monitor autoimmune hepatitis in the National Health Service in England: an economic evaluation. BMJ Open. 2022 Sep 8;12(9):e058999. doi: 10.1136/bmjopen-2021-058999.

  PMID: 36691214 DERIVED

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rajarshi Banerjee, MD,PhD

  Perspectum

  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 5, 2019
• First Posted: June 7, 2019
• Study Start: June 26, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)