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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 1, 2023

Interventions

  • Radiation: MRI
    • Research MRI

Arms, Groups and Cohorts

  • Alcoholic Liver Disease Patients

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Cleveland Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Srinivasan Dasarathy, Staff – The Cleveland Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.