AIH Risk Stratification With Multiparametric MRI

Autoimmune Hepatitis Clinical Trial

Official title:

AIH Risk Stratification With Multiparametric MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04339621
• Other study ID #: EC-88
• Status: Terminated
• Start date: October 20, 2020
• Est. completion date: April 15, 2023

Study information

• Verified date: November 2023
• Source: Perspectum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 15, 2023
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis
• Hepatitis, Autoimmune

Intervention

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

Locations

Country	Name	City	State
United States	Touchstone Medical Imaging	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Perspectum

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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