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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03113929
Enrollment
20
Registered
2017-04-14
Start date
2017-07-10
Completion date
2027-12-01
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Liver Disease

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.

Interventions

RADIATIONMRI

Research MRI

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
T1 relaxation time1 hourQuantification of T1 relaxation time assessed over 1 hour MRI
Hepatic fat fraction1 hourQuantification of hepatic fat fraction assessed over 1 hour MRI
ASL (Arterial spin labeling) based perfusion measurements1 hourQuantification of ASL (Arterial spin labeling) based perfusion measurement in Quantification of arterial spin labeling assessed over 1 hour MRI
Signs of portal hypertension1 hourAsses the presence or absence of splenomegaly and varices over a 1 hour MRI to help determine portal hypertension

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026