跳至主要内容
临床试验/NCT03113929
NCT03113929进行中(未招募)不适用

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

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
1
主要终点
Hepatic fat fraction

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects > 18 years of age, with the clinical diagnosis of ALD and native liver will be eligible

排除标准

  • 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)

结局指标

主要结局

Hepatic fat fraction

时间窗: 1 hour

Quantification of hepatic fat fraction assessed over 1 hour MRI

T1 relaxation time

时间窗: 1 hour

Quantification of T1 relaxation time assessed over 1 hour MRI

ASL (Arterial spin labeling) based perfusion measurements

时间窗: 1 hour

Quantification of ASL (Arterial spin labeling) based perfusion measurement in Quantification of arterial spin labeling assessed over 1 hour MRI

Signs of portal hypertension

时间窗: 1 hour

Asses the presence or absence of splenomegaly and varices over a 1 hour MRI to help determine portal hypertension

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Srinivasan Dasarathy

Staff

The Cleveland Clinic

研究点 (1)

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