Quantitative MRI for Non-invasive Assessment of Severity of Alcoholic Liver Disease (ALD)

Study Overview
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Brief Summary
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The current goal in the treatment of Alcoholic Liver Disease (ALD) is to manage ALD-associated complications as there are no disease-specific therapies. Identifying disease-specific therapies to slow ALD progression is critical to improving the outcomes in these patients. Despite preclinical treatment studies in animal models that have shown promise, clinical trials in ALD patients have been limited by the absence of sensitive, quantitative methods for identifying severity and monitoring progression of liver disease. The rates of progression of liver disease in ALD are variable and difficult to predict, which makes assessments of therapies difficult. Clinical measures of hepatic or biliary disease (e.g., bilirubin, transaminases) may be normal, only mildly elevated and/or stable despite ongoing organ damage. Liver biopsies are diagnostic, but are invasive and are of limited value for longitudinal monitoring. Currently clinical imaging, including standard volumetric imaging (MRI and ultrasonography) and hepatic fibrosis assessment (e.g. Fibroscan) are also of limited utility in fully staging disease severity and monitoring progression in ALD. The absence of clinically available methods for accurately determining the severity and progression of liver disease progression in ALD has limited implementation of clinical trials using novel therapeutic agents. Development of non-invasive imaging biomarkers to assess rates of liver progression will overcome this barrier and allow for such studies to be undertaken. This study intends to perform a one-time MRI on patients with ALD to search for these biomarkers that can improve the diagnosis and treatment of ALD patients.

Official Title
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Quantitative MRI for Non-invasive Assessment of Severity of Alcoholic Liver Disease (ALD)

Conditions
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Alcoholic Liver Disease

Intervention / Treatment
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* Radiation: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects > 18 years of age, with the clinical diagnosis of ALD and native liver will be eligible Exclusion Criteria: Subjects with history of combined organ transplantation Presumed or biopsy-confirmed ascending cholangitis within the last 3 months Contraindications for MRI (e.g. pacemakers, implants/hardware that is not MRI compatible)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alcoholic Liver Disease Patients<br> | Radiation: MRI<br>* Research MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1 relaxation time | Quantification of T1 relaxation time assessed over 1 hour MRI | 1 hour | 
| Hepatic fat fraction | Quantification of hepatic fat fraction assessed over 1 hour MRI | 1 hour | 
| ASL (Arterial spin labeling) based perfusion measurements | Quantification of ASL (Arterial spin labeling) based perfusion measurement in Quantification of arterial spin labeling assessed over 1 hour MRI | 1 hour | 
| Signs of portal hypertension | Asses the presence or absence of splenomegaly and varices over a 1 hour MRI to help determine portal hypertension | 1 hour |