AIH Risk Stratification With Multiparametric MRI

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.

Study Overview

• Status: Terminated
• Conditions: Autoimmune Hepatitis
• Intervention / Treatment: Device: LiverMultiscan

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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

• Study Contact: Name: Apurva Modi, MD; Phone Number: 817-922-2571; Email: aourva.modi@bswhealth.org
• Study Contact Backup: Name: Theresa Cheyne; Phone Number: 817-922-2571; Email: theresa.cheyne@bswhealth.org

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Touchstone Medical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Naive; 20 patients with AIH will be recruited that will be treatment naive at the time of recruitment.	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
Treatment cessation review; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH).	Performance of cT1, as assessed by Area Under the Receiver Operating Curve, for predicting those patients likely to relapse following treatment cessation.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the utility of cT1 to monitor active disease along the clinical pathway	Performance of cT1 to predict active disease, as defined by histology and assessed by Area Under the Receiver Operating Curve, as part of the monitoring pathway	36 months
To assess the correlation between cT1 and other clinically relevant outcomes and biomarkers such as blood biomarkers, autoimmune markers, ultrasound, histology and patient-reported outcome measures	Correlation between cT1 and other clinically relevant outcomes and biomarkers used in the AIH pathway (LFTs, autoimmune markers, ultrasound, histology and patient reported outcome measures)	36 months
To collect health economic information about adding LMS into standard care pathway	To quantify the potential reduction in patient management costs by reducing unnecessary appointments	36 months

Collaborators and Investigators

• Sponsor: Perspectum

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Liver Biopsy; Autoimmune hepatitis; LiverMultiscan
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Autoimmune Diseases; Liver Diseases; Hepatitis, Chronic; Hepatitis; Hepatitis, Autoimmune
• Other Study ID Numbers: EC-88

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No