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

Active, not recruiting

• Conditions: Alcoholic Liver Disease
• Interventions: Radiation: MRI

• Registration Number: NCT03113929
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-07-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alcoholic Liver Disease Patients	MRI	-

Primary Outcome Measures

Name	Time	Method
Hepatic fat fraction	1 hour	Quantification of hepatic fat fraction assessed over 1 hour MRI
T1 relaxation time	1 hour	Quantification of T1 relaxation time assessed over 1 hour MRI
ASL (Arterial spin labeling) based perfusion measurements	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	1 hour	Asses the presence or absence of splenomegaly and varices over a 1 hour MRI to help determine portal hypertension

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States