跳至主要内容
临床试验/NCT05385237
NCT05385237招募中不适用

Noninvasive Stage Identification of Hepatic Fibrosis Using 4D-MRI

University Hospital, Basel, Switzerland4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年8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
招募中
发起方
入组人数
200
试验地点
4
主要终点
Change in the spatial-temporal deformation fields

研究概览

简要总结

To date, no specific treatment options exist for liver diseases, and there is a large global effort to find drugs that will halt liver disease progression in these patients.Liver fibrosis staging is essential as a diagnostic/prognostic measure and there is an increasing demand for accurate non-invasive liver stiffness measurement tools. This research project proposes a novel MR-based quantitative Liver Deformation Biomarker (qLDB) approach for non-invasive liver fibrosis assessment by using a new technique called 4D-MRI. 4D-MRI allows to overcome the limitations of currently used techniques. Hence, 4D-MRI may help to identify a novel biomarker for non-invasive staging of liver fibrosis , and therefore improve the final diagnosis of patients suffering from liver diseases.

详细描述

Chronic liver diseases represent a rising global health threat. A prolonged inflammatory state leads to progressive fibrosis that can result in liver cirrhosis associated with serious complications including loss of liver function or hepatocellular carcinoma development. A particularly strong increase in the prevalence, morbidity, and mortality occurs in fatty liver disease, such as non-alcoholic fatty liver disease (NAFLD) and alcohol-related liver disease; (ALD).To date, no specific treatment options for these conditions exist, and there is a large global effort to find drugs that will halt liver disease progression in these patients. Liver fibrosis staging is essential as a diagnostic/prognostic measure and there is an increasing demand for accurate non-invasive liver stiffness measurement tools. This research project proposes a novel MR-based quantitative Liver Deformation Biomarker (qLDB) approach for non-invasive liver fibrosis assessment by using a new technique called 4D-MRI. This technique makes it possible to overcome limitations in currently used techniques, i.e. to capture the abdominal organs with high spatial resolution in 3-dimensions at a high frame rate of 2-3 Hz and enabled an entirely new insight into the human body. The final diagnosis (i.e., stage of fibrosis) is based on quantifying changes of the liver's mechanical properties by dynamic magnetic resonance (MR) measurements and comparing the liver's elastic deformation with healthy livers. This innovative methodology allows for the first time to quantitatively measure the elastic deformation of organs during free-breathing and for an extended period, since no harmful X-rays are required. The hypothesis of the study is that the mechanical changes a liver undergoes during liver disease progression are visible in 4D-MRI data sets as a reduced elasticity. This will be assessed using our 4D-MRI approach taking into account the liver's deformation induced by natural respiration and also cardiac pulsation. The primary objective of the study is to compare liver deformation, induced at different respiratory breath-hold positions, by respiratory motion, and cardiac pulsation, between healthy subjects and patients with histologically confirmed liver cirrhosis in order to find a novel biomarker for non-invasive staging of liver fibrosis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Statistician blinded for analysis

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

  • age ≥ 18 years
  • (a) Patients with histologically confirmed chronic liver disease, including NAFLD, ALD, viral hepatitis B and C, genetic (e.g. Wilson disease, hemochromatosis) or autoimmune liver disease
  • (b) Patients with acute liver inflammation or cardiac blood congestion to the liver (as assessed by laboratory values, imaging findings and clinical history)
  • ability to understand and consent to participate in this study

排除标准

  • Medical implant like cardiac pacemaker, pump, hip prosthesis
  • Metallic objects in the body (e.g. splinters after an accident)
  • Persons who have undergone brain or cardiac surgery
  • Claustrophobia
  • Body Weight >140kg or as provided by the MR manufacturer
  • Pregnant and lactating women
  • (a) Active hepatocellular carcinoma (HCC) (remark: patients with a history of HCC and curative treatment can be included)
  • (a) CHILD C cirrhosis
  • (a) and (b) Patients with overt ascites (except if they respond to diuretic treatment and the ascites resolves)
  • (c) Metabolic syndrome, BMI >30 kg/m2
  • (c) Acute or chronic liver disease
  • Patients not willing or able to give a written informed consent

研究组 & 干预措施

4D-MRI assessment for patients with liver diseases

Experimental

patients with chronic liver diseases, acute liver inflammation or cardiac blood congestion to the liver will be assessed by MRI

干预措施: 4D-MRI (Diagnostic Test)

4D-MRI assessment for healthy volunteers (control group)

Experimental

healthy control subjects will be assessed by MRI

干预措施: 4D-MRI (Diagnostic Test)

结局指标

主要结局

Change in the spatial-temporal deformation fields

时间窗: 90 days

To find out whether the spatial-temporal deformation fields, as induced by natural respiration and cardiac pulsation, and as assessed by dynamic MR measurements, are changed in liver cirrhosis if compared to healthy livers.

次要结局

  • Assessment of mechanical changes with 4D-MRI(90 days)
  • Superiority Assessment of 4D-MRI vs.US elastography(90 days)
  • Superiority Assessment of 4D-MRI vs, standard MRI(90 days)
  • Differential Diagnosis(90 days)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (4)

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