The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Elasticity measurements comparison between Liver Incytes MR Elastography
研究概览
简要总结
The main purpose of this study is to compare the effectiveness of various non-invasive elastography techniques at determining liver stiffness measures in human subjects. Specifically, the investigators are comparing MRE and FibroScan to Vibroelastography (VE, Liver Incytes System). These techniques are used to measure stiffness in the liver.
详细描述
The Liver Incytes system allows for full visualization of the liver with the low cost and portability of ultrasound. It is an adjustable multi-frequency technique, which can show large areas of the organ as volumetric elasticity maps. The device uses the Shear Wave Absolute Vibro-Elastography (S-WAVE) method.
The primary objective of the study is to determine the relationship between the elasticity results from Liver Incytes and those of MR Elastography. In addition to stiffness measurements, the relationship between the Liver Incytes attenuation measurements and MR-PDFF will also be evaluated.
As secondary objectives, the ability of Liver Incytes to correctly stage patients using MRE as the standard (unless biopsy is available), looking specifically at the ability to measure mild and advanced fibrosis.
In additional to performance objectives, the safety, tolerability and usability of the device will be assessed.
This is a prospective, open label, validation study of the Liver Incytes system in comparison to MR results (as gold standard) in patients with liver disease or suspected liver disease. Approximately 100 subjects may be enrolled in this study which will take place at clinical centers across Canada and the United States. Study participants should be distributed primarily across the 4 stages of fibrosis, with secondary consideration of the three stages of steatosis.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, 19-75 years old
- •Healthy volunteers or Patients with evidence of NAFLD such as one of the following:
- •Previous liver biopsy consistent with NAFLD OR
- •Evidence of hepatic steatosis on non-invasive assessment by one or more of the following criteria:
- •Abdominal ultrasound within 12 months
- •MRI-PDFF (greater than 12%) within 12 month
- •FibroScan CAP score > 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (>8kPa) within 12 months
- •Able to understand the informed consent form, study procedures and willing to participate in study
- •If female and of child bearing potential, must agree to practice a highly effective contraception method.
排除标准
- •Active viral hepatitis
- •a. Patients with cured HCV (those with history of treatment and have Sustained Viral Response for 12 weeks (SVR12)) or controlled HBV with no viral detected for more than 6 months are eligible
- •Decompensated cirrhosis (history of ascites, encephalopathy, or variceal bleeding)
- •ALT or AST > 5 x ULN on historical blood work within the past 3 months
- •BMI greater than 40 kg/m2 (or using cutoff based on MRI)
- •Other known causes of chronic liver disease
- •Individuals with history of persistent ethanol abuse (alcohol consumption > 20g etoh/day for women, > 40 g etoh/day for men)
- •Individuals with surgically removed gallbladder
- •Pregnant or planning to become pregnant while enrolled in this study
- •Other conditions which would exclude patients from entering an MRI
研究组 & 干预措施
Open-label
Volunteers who have agreed to participate in the study will have their liver scanned using the FibroScan, VE (Liver Incytes System) and MRE techniques.
干预措施: Liver Incytes System (Device)
结局指标
主要结局
Elasticity measurements comparison between Liver Incytes MR Elastography
时间窗: 12 months
Elasticity measurements (kPa) from the Liver Incytes system and the MR system will be compared to determined whether the reported stiffness of the tissue (mean and 95% confidence intervals) are equivalent by concordance correlation coefficient and 95% confidence intervals.
Determination of Liver Incytes' discriminatory ability of liver stiffness as measured by fibrosis staging
时间窗: 12 months
Liver Incytes liver stiffness values will be compared to values obtained using MRE to determine the cutoff values for the Liver Incytes System for each level of fibrosis staging. For each stage of fibrosis as defined by MRE, Area Under the Receiver Operating Curve (AUROC) for Liver Incytes elasticity will be calculated and the cutoff maximizing the sensitivity and specificity will be determined.
次要结局
- Incidence of and Device Deficiencies(12 months)
- Comparison between Liver Incytes' and FibroScan's steatosis staging capabilities(12 months)
- Attenuation measurements comparison between the Liver incytes System and MRI Proton Density Fat Fraction(12 months)
- Comparison between Liver Incytes' and FibroScan's fibrosis staging capabilities(12 months)
- Incidence of Adverse Events(12 Months)