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

Alcoholic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03113929
• Other study ID #: 16-1663
• Status: Active, not recruiting
• Start date: July 10, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Radiation:
• MRI
Research MRI

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T1 relaxation time	Quantification of T1 relaxation time assessed over 1 hour MRI	1 hour
Primary	Hepatic fat fraction	Quantification of hepatic fat fraction assessed over 1 hour MRI	1 hour
Primary	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
Primary	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