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临床试验/NCT02565446
NCT02565446已完成不适用

Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
243
试验地点
1
主要终点
The role of MRE as a non-invasive tool for estimation of inflammation and fibrosis in NAFLD.

研究概览

简要总结

A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information but yet is not available non-invasively. Recent murine studies from this group of investigators has identified that MRE technology can be adapted to non-invasively detect these conditions. Implementing this into the practice will transform it by obviating the need for invasive liver biopsies in patients suspected of having such forms of suspected liver disease. This will differentiate Mayo from other institutions where such technology is not available.

An additional aim of this study is to examine the impact of obstructive sleep apnea (OSA) on the pathogenesis of nonalcoholic fatty liver disease (NAFLD), both common comorbidities of obesity. Recent evidence indicates a potential link between OSA and severity of NASH and fibrosis, but the mechanisms of OSA- associated hypoxia on liver disease progression in NAFLD is unclear. This study offers the unique opportunity to analyze this association, as the study population will undergo routine evaluation for OSA, as part as the preoperative work-up prior to bariatric surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Age ≥ 18 years
  • •Verbal and written fluency of the English Language
  • •Able to consent

排除标准

  • •Absolute contraindications to MRI including pacemaker, automatic implantable cardioverter/defibrillator (AICD) device, cochlear implant, ventriculoperitoneal (VP) shunt, aneurysm clip, deep brain stimulator, and severe claustrophobia
  • •Absolute contraindications to liver biopsy including coagulopathy
  • •History of decompensated cirrhosis complicated by one or more of the following: esophageal variceal hemorrhage, ascites, hepatic encephalopathy, or spontaneous bacterial peritonitis.
  • •Women who are pregnant or breastfeeding
  • •History of liver transplantation or hepatic resection
  • •History of primary or secondary hepatic malignancy
  • •Current or previous excessive alcohol consumption within 6 months of study enrollment defined as > 30 grams/day for men and > 20 grams/day for women
  • •Current or prior history of therapy for underlying liver disease including interferon-based medications, other antiviral agents, immunomodulatory therapy, biologic response modifier therapy, and complementary/alternative medications including (but not encompassing) milk thistle
  • •Any severe medical condition that, in the opinion of the Principal Investigator, would serve as an exclusion criterion for study enrollment

研究组 & 干预措施

Clinical

Experimental

Subjects who received abdominal surgery for non-liver related indications (cholecystectomy, pancreatic cyst resection)

干预措施: Magnetic Resolution Elastography (MRE) (Procedure)

Bariatric

Experimental

Obese adult subjects who are scheduled to undergo bariatric surgery

干预措施: Magnetic Resolution Elastography (MRE) (Procedure)

结局指标

主要结局

The role of MRE as a non-invasive tool for estimation of inflammation and fibrosis in NAFLD.

时间窗: The outcome (correlation of liver histology with MR elastogram) will be assessed once, at the time of outpatient biopsy, then again 1 year later with a second biopsy and a second MRE. Outcomes will be assessed after second biopsy.

120 participants evaluated at Mayo clinic with a diagnoses of NAFLD who are at risk to have NASH. All subjects will undergo an MRE and outpatient liver biopsy.The liver tissue will be assessed for fat, inflammation, and fibrosis by pathology. We are looking for differentiation of simple steatosis from steatohepatitis and steatohepatitis with fibrosis by non-invasive measures such as MRE.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alina M. Allen

Principal Investigator

Mayo Clinic

研究点 (1)

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