None listed
Conditions
Brief summary
The purpose of this study is to explore the potential for a non-invasive MRI-based method to diagnose and quantitate liver fibrosis. The results will be compared to the current standard of care which is the histopathologists visual examination of tissue obtained via an invasive liver biopsy as well as FibroScan an ultrasound-based liver imaging method.
Interventions
This study will aim to recruit only those chronic HCV patients who have previously undergone a liver transplant (Group A). However, in order to meet recruitment timelines, patients who have chronic HCV infection but who have not had a liver transplant (Group B) will also be included in the study.
Each study participant (both those from Group A and Group B) will undergo an abdominal MRI examination on two separate occasions (at Visits 1 and 2 which will be performed 35-45 days apart). MR images
This study will aim to recruit only those chronic HCV patients who have previously undergone a liver transplant (Group A). However, in order to meet recruitment timelines, patients who have chronic HCV infection but who have not had a liver transplant (Group B) will also be included in the study. Each study participant (both those from Group A and Group B) will undergo an abdominal MRI examination on two separate occasions (at Visits 1 and 2 which will be performed 35-45 days apart). MR images will be acquired at each visit both before and after the administration of gadoterate (Dotarem(R)).
Sponsors
Resonance Health Analysis Services
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 Either: 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.
Exclusion criteria
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).
Outcome results
None listed