AIH Risk Stratification With Multiparametric MRI
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Perspectum
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Any contraindication to MRI scanning
- •Any clinically significant medical or psychiatric condition
结局指标
主要结局
To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH).
时间窗: 36 months
Performance of cT1, as assessed by Area Under the Receiver Operating Curve, for predicting those patients likely to relapse following treatment cessation.
次要结局
- 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)
- To assess the utility of cT1 to monitor active disease along the clinical pathway(36 months)