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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Alcoholic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI

Radiation

Research MRI

Primary outcomes

T1 relaxation time

Time frame: 1 hour

Quantification of T1 relaxation time assessed over 1 hour MRI
Hepatic fat fraction

Time frame: 1 hour

Quantification of hepatic fat fraction assessed over 1 hour MRI
ASL (Arterial spin labeling) based perfusion measurements

Time frame: 1 hour

Quantification of ASL (Arterial spin labeling) based perfusion measurement in Quantification of arterial spin labeling assessed over 1 hour MRI
Signs of portal hypertension

Time frame: 1 hour

Asses the presence or absence of splenomegaly and varices over a 1 hour MRI to help determine portal hypertension

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2027
Study completion: 2027
First posted: Apr 14, 2017
Registry last updated: Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting