ACTRN12612000357853已完成未知
PUMA: A pilot study to assess the utility of magnetic resonance imaging in the staging of liver fibrosis.
Resonance Health Analysis Services0 个研究点目标入组 30 人开始时间: 2012年3月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female patients at least 18 years of age.
- •2. Ability to provide written informed consent prior to entering the study.
- •3. Willingness and ability to comply with scheduled visits and all study related procedures.
- •4. Confirmed clinical diagnosis of chronic HCV infection
- •i) Group A: undergone a liver transplant for HCV end-stage liver disease at least 12 months prior to Screening Visit
- •ii) Group B: have not undergone a liver transplant
- •5. Metavir fibrosis stage 1, 2 or 3 as assessed by liver biopsy performed a maximum of 6 months prior to the Screening visit.
- •6. For all patients, liver biopsy tissue samples must be available for central reading for determination of the Ishak and Metavir fibrosis score, assessment of collagen content and measurement of liver fibrosis via computer-assisted image analysis.
排除标准
- •1. Metavir fibrosis stage 0 or 4 assessed by liver biopsy
- •2. Evidence of liver disease caused by aetiology other than HCV, including alcohol.
- •3. Liver Transplant for HCV end stage liver disease less than 12 months prior to study screening visit.
- •4.Decompensated severe liver disease.
- •5. HCC or suspicion of HCC clinically or on ultrasound
- •6. Presence of HIV
- •7. HBV co-infection
- •8. EBV co-infection
- •9. Autoimmune disease history
- •10. ALT < 1.5 x ULN last visit prior to Baseline visit.
- •11. Renal impairment (creatinine >1.5ULN) or hepatorenal syndrome.
- •12. Pancreatitis
- •13. Ribavirin/Interferon concurrent treatment
- •14. Alcohol consumption history (M:> 21 drinks/week; F: 14 drinks/week)
- •15. Body Mass Index (BMI) > 27.5kg/m squared.
- •16. History of Type II Diabetes
- •17. Pregnant women - positive BHCG
- •18. patients with eGFR < 30mL/min
- •19. MRI contraindication
- •20. gadolinium contrats agent intolerance or contra-indication (as per the RANZCR guidelines Jan 2008).
研究者
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