Study Stopped
Lack of recruitment
AIH Risk Stratification With Multiparametric MRI
1 other identifier
observational
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2020
CompletedFirst Posted
Study publicly available on registry
April 9, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2023
CompletedNovember 22, 2023
November 1, 2023
11 months
April 6, 2020
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
To assess the utility of cT1 to monitor active disease along the clinical 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
36 months
To collect health economic information about adding LMS into standard care pathway
36 months
Study Arms (2)
Treatment Naive
20 patients with AIH will be recruited that will be treatment naive at the time of recruitment.
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
Interventions
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
To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH)
You may qualify if:
- 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)
- + years of age.
- Ability to give informed consent
You may not qualify if:
- Any contraindication to MRI scanning
- Any clinically significant medical or psychiatric condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Perspectumlead
Study Sites (1)
Touchstone Medical Imaging
Fort Worth, Texas, 76104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2020
First Posted
April 9, 2020
Study Start
October 20, 2020
Primary Completion
September 8, 2021
Study Completion
April 15, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11