Clinical trial NCT04339621: AIH Risk Stratification With Multiparametric MRI
Official title: AIH Risk Stratification With Multiparametric MRI
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Autoimmune Hepatitis
Keywords: Autoimmune hepatitis
LiverMultiscan
MRI
Liver Biopsy
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH)

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH).
timeFrame: 36 months
Secondary outcomes:
measure: To assess the utility of cT1 to monitor active disease along the clinical pathway
timeFrame: 36 months
measure: 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
timeFrame: 36 months
measure: To collect health economic information about adding LMS into standard care pathway
timeFrame: 36 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Touchstone Medical Imaging
state: Texas
Study officials:
References: