PUMA: A pilot study to assess the utility of magnetic resonance imaging in the staging of liver fibrosis.

Not Applicable

Completed

• Conditions: Patients with liver disease due to chronic hepatitis C virus (HCV) infection who have previously undergone a liver transplant (Group A); Infection - Other infectious diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12612000357853
• Lead Sponsor: Resonance Health Analysis Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified