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NCT03113929 · ClinicalTrials.gov registry record
Quantitative MRI for Non-invasive Assessment of Severity of Alcoholic Liver Disease (ALD)
A clinical trial of Alcoholic Liver Disease, sponsored by The Cleveland Clinic.
- Active
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT03113929: Active study of Alcoholic Liver Disease, sponsored by The Cleveland Clinic.
NCT03113929 is a study of Alcoholic Liver Disease that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 20 participants, below the 73-participant average among 5 other Alcoholic Liver Disease trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03113929, a study of Alcoholic Liver Disease, is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Quantification of T1 relaxation time assessed over 1 hour MRI
Conditions Studied
Interventions
- RADIATION MRI
Study Locations (1)
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2027-12-01 |
What the registry record for NCT03113929 still lists
NCT03113929 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 73-participant average among 5 other Alcoholic Liver Disease trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Alcoholic Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which MRI is the first listed.
NCT03113929 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03113929 about?
NCT03113929 is a clinical study titled "Quantitative MRI for Non-invasive Assessment of Severity of Alcoholic Liver Disease (ALD)". 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 treatme...
What is the current status of trial NCT03113929?
This trial is currently active not recruiting. The enrollment target is 20 participants. The study started on 2017-07-10. Estimated completion is 2027-12-01.
What conditions does trial NCT03113929 study?
This clinical trial studies the following conditions: Alcoholic Liver Disease.
What interventions are being tested in trial NCT03113929?
The interventions under investigation include: MRI (RADIATION).
Who is sponsoring clinical trial NCT03113929?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03113929 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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