Prospective Detection of Liver Fibrosis With MRI Compared to Fibroscan and Blood Tests
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- PV Flow
研究概览
简要总结
Patients with chronic liver disease are at high risk of developing liver scarring (fibrosis), with ultimate risks of cirrhosis and liver cancer that may require liver transplant. The investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI) techniques (MR diffusion, perfusion and elastography) to assess the degree of liver damage in patients with chronic liver disease. These techniques combined could reach high diagnostic performance for detection of liver fibrosis; and could decrease the number of liver biopsies, which have risks and sample only a small portion of the liver.
详细描述
Patients with chronic hepatitis have increased risks of liver damage, including fibrosis and cirrhosis, which may eventually lead to hepatocellular carcinoma and end-stage liver disease requiring liver transplantation. These diseases are/will be the source of enormous health care costs and morbidity/mortality in the US.
Most hepatologists still rely on liver biopsy findings in patients newly diagnosed with chronic hepatitis, which enables the assessment of liver damage (fibrosis and inflammation). Liver biopsy has limitations, including cost, invasiveness, poor patient acceptance, limited sampling, inter-observer variability and is difficult to repeat.
Non invasive tests to capture the extent of liver damage at a larger scale are urgently needed. These will gain more acceptance among patients and hepatologists.
In this proposal, the investigators would like to test and validate non invasive MRI methods based on advanced MR diffusion, perfusion and elastography techniques for the detection of fibrosis and cirrhosis in patients with chronic hepatitis. In order to improve the diagnostic performance of MRI, the investigators would like to build and validate a predictive model based on advanced functional MRI metrics (diffusion, perfusion and elastography). If validated, this novel non invasive algorithm will not only decreases the number of liver biopsies, but also enable earlier diagnosis of liver fibrosis when antiviral treatment is more effective, and enable a comprehensive evaluation of the liver (to assess for cirrhosis, portal hypertension and hepatocellular cancer).
This could significantly reduce the cost of care, could become a useful tool for testing new antifibrogenic and antiviral drugs in chronic viral hepatitis, and could be used to follow patients for detection of progression to cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 是
入选标准
- •Chronic liver disease (including viral hepatitis, alcoholic hepatitis, non alcoholic steatohepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, etc..)
- •18 years of age and older
- •Liver biopsy (percutaneous or transjugular or surgical) performed within 6 months, as part of routine clinical care.
- •Liver transplant or liver resection performed within 6 months, as part of routine clinical care.
- •Patient is able to give informed consent for this study and agrees to provide a blood sample
- •Control group
- •Patients without history of liver disease and healthy volunteers
- •18 years of age and older
- •Subject is able to give informed consent for this study and agrees to provide a blood sample
排除标准
- •Age less than 18 years
- •Unable or unwilling to give informed consent
- •Contra-indications to MRI
- •Electrical implants such as cardiac pacemakers or perfusion pumps
- •Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- •Ferromagnetic objects such as jewelry or metal clips in clothing
- •Pregnant subjects
- •Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions.
研究组 & 干预措施
Perfusion MRI
chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months.
干预措施: Perfusion MRI (Drug)
结局指标
主要结局
PV Flow
时间窗: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)
Sub-Study I Portal Venous Flow - forward flow during systole and early diastole, and flow reversal after atrial contraction.The average PV area was extracted, and PV flow was computed as the multiplication of area and velocity.
PV Velocity
时间窗: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)
Sub-Study I Portal Venous Flow Velocity - The mean velocity of the region of interest (ROI) was extracted for each one of the 25 phase images, and the time average was computed.
LS-MRE for Sub-Study I
时间窗: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)
Sub-Study I Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images.
True Diffusion Parameter (D)
时间窗: Fasting State Multiparametric MRI Scan (an average of 60 min) Scan
Sub-Study II True Diffusion Parameter - D- describes water diffusion in tissue independently from the effects of capillary perfusion; it is obtained from bi-exponential fitting of MRI diffusion signal acquired over a range of high and low diffusion-weighting factors (b-values) Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis
LS-MRE Fibrosis State for Sub Study II
时间窗: Fasting State Multiparametric MRI Scan (an average of 60 min)
Sub-Study II Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images. Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis
LS-TE
时间窗: Fasting transient elastography, average duration 10 min
Sub-Study II Liver Stiffness with transient elastography (TE) (LS-TE) - a non-invasive modality of liver fibrosis detection: a shear wave is sent into the liver through a small transducer attached to an ultrasound probe, and the velocity of the wave is measured as it passes through the liver; shear wave velocity is then converted to stiffness, measured in kilopascals (kPa) Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis
MTT
时间窗: Fasting State Multiparametric MRI Scan (an average of 60 min)
Sub-Study II Mean Transit Time (MTT) - Liver Mean Transit Time of Contrast Agent through the tissue of interest from Dynamic Contrast Enhanced MRI Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis
次要结局
- Spleen TTP(Fasting State Multiparametric MRI Scan (an average of 60 min))
- Liver Upslope From DCE-MRI(Fasting State Multiparametric MRI Scan (an average of 60 min))
- Liver Time to Peak (TTP) for PH(Fasting State Multiparametric MRI Scan (an average of 60 min))
- LS-MRE Portal Hypertension for Sub Study III(Fasting State Multiparametric MRI Scan (an average of 60 min))
- Spleen Volume(Fasting State Multiparametric MRI Scan (an average of 60 min))
- Spleen Caudocranial Diameter(Fasting State Multiparametric MRI Scan (an average of 60 min))
- PH Imaging Score(Fasting State Multiparametric MRI Scan (an average of 60 min))
- LSLU(Fasting State Multiparametric MRI Scan (an average of 60 min))
- Liver DV(Fasting State Multiparametric MRI Scan (an average of 60 min))
研究者
Bachir Taouli
Associate Professor
Icahn School of Medicine at Mount Sinai