NCT04339621

AIH Risk Stratification With Multiparametric MRI

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Perspectum · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Autoimmune Hepatitis

Interventions

Type	Name	Description
DEVICE	LiverMultiscan	The LiverMultiscan is a quick 15 minute, contrast free MRI scan that provides three metrics on liver health namely fat, iron and fibro-inflammatory scores

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-09-08
• Completion: 2023-04-15
• First posted: 2020-04-09
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study