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

NCT03113929 | Active Not Recruiting

• 1 other identifier: 16-1663
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcoholic Liver Disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Alcoholic Liver Disease Patients

Radiation: MRI

Interventions

MRI RADIATION

Research MRI

Alcoholic Liver Disease Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All subjects \> 18 years of age, with the clinical diagnosis of ALD and native liver will be eligible

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 14, 2017
• Study Start: July 10, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)