Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
11 participants
OBSERVATIONAL
2020-10-20
2023-04-15
Brief Summary
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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
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Treatment Naive
20 patients with AIH will be recruited that will be treatment naive at the time of recruitment.
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 clinically significant medical or psychiatric condition
18 Years
ALL
No
Sponsors
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Perspectum
INDUSTRY
Responsible Party
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Locations
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Touchstone Medical Imaging
Fort Worth, Texas, United States
Countries
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Other Identifiers
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EC-88
Identifier Type: -
Identifier Source: org_study_id