Clinical trial NCT03113929: Quantitative MRI for Non-invasive Assessment of Severity of Alcoholic Liver Disease (ALD)
Official title: Quantitative MRI for Non-invasive Assessment of Severity of Alcoholic Liver Disease (ALD)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alcoholic Liver Disease
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: T1 relaxation time
timeFrame: 1 hour
measure: Hepatic fat fraction
timeFrame: 1 hour
measure: ASL (Arterial spin labeling) based perfusion measurements
timeFrame: 1 hour
measure: Signs of portal hypertension
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References: