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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcoholic Liver Disease
• Intervention / Treatment: Radiation: MRI

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All subjects with a diagnosis of alcoholic liver disease that have a native liver and are at least 18 years of age are eligible to participate.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alcoholic Liver Disease Patients	Radiation: MRI; Research MRI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcohol-Induced Disorders; Liver Diseases, Alcoholic
• Other Study ID Numbers: 16-1663

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No