AIH Risk Stratification With Multiparametric MRI

Perspectum

Status: Terminated

Conditions: Autoimmune Hepatitis

Treatments: Device: LiverMultiscan

Study type: Observational

Funder types: Industry

Identifiers

NCT04339621

EC-88

Details and patient eligibility

About

The primary aim of this study is to investigate whether the baseline cT1 can predict those whose condition relapses following treatment withdrawal.

The secondary aim is to investigate correlation of cT1 with histology to explore utility as a monitoring tool.

A total of 97 patients with AIH will be recruited and divided into 2 arms. 20 of which will be treatment naive and the other 77 will have been on treatment for the past 18-24 months and will be coming in for therapy cessation review.

Full description

Patients with AIH who have been undergoing immunosuppressive treatment for 18-24 months will be invited for a series of multiparametric MRI (mpMRI) scans to assess the utility of LMS for monitoring characteristics of the disease.

This will be a prospective, cross-sectional, observational study recruiting 97 participants (20 of which will be treatment naïve at recruitment) from those patients scheduled for a liver biopsy for therapy cessation review. They will be consented and invited for a LiverMultiScan.

All patients whose treatment is ended based on histology results will be followed up over the subsequent 12 months, and those that experience a biochemical relapse or 'flare-up' will be invited for a second LiverMultiScan prior to their scheduled liver biopsy.

All participants will attend their planned outpatient hepatology appointment with their doctor, who will document the intended treatment plan for each participant in line with their usual care pathway. Their MRI scan will then be scheduled for the same day as their outpatient appointment or within a 7-day window after their appointment with the consultant.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing management for AIH being considered for treatment cessation
• Patients diagnosed with AIH, are treatment naïve, and will be undergoing biopsy as per clinical pathway
• Diagnostic biopsy prior to cessation of treatment (where possible)
• 18+ years of age.
• Ability to give informed consent

Exclusion criteria

• Any contraindication to MRI scanning
• Any clinically significant medical or psychiatric condition

Trial design

11 participants in 2 patient groups

Treatment Naive

Description:

20 patients with AIH will be recruited that will be treatment naive at the time of recruitment.

Treatment:

Device: LiverMultiscan

Treatment cessation review

Description:

77 AIH patients will be recruited who will have been on treatment for the past 18-24 months and will be coming in to meet their physician to review treatment cessation options

Treatment:

Device: LiverMultiscan