Quantitative MRI for Non-invasive Assessment of Severity of Alcoholic Liver Disease (ALD)
Status: | Active, not recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/1/2019 |
Start Date: | July 10, 2017 |
End Date: | December 1, 2020 |
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.
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.
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)
We found this trial at
1
site
2049 E 100th St
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Srinivasan Dasarathy, MD
Phone: 216-636-5247
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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