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

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Alcoholic Liver Disease

Treatments: Radiation: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT03113929

16-1663

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

20 participants in 1 patient group

Alcoholic Liver Disease Patients

Treatment:

Radiation: MRI