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CompletedACTRN12612000357853

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

Sponsor

Resonance Health Analysis Services

Enrollment

30 participants

Start Date

Jun 7, 2011

Study Type

Observational

Conditions

Patients with liver disease due to chronic hepatitis C virus (HCV) infection who have previously undergone a liver transplant (Group A)

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria9

  • Male or female patients at least 18 years of age.
  • Ability to provide written informed consent prior to entering the study.
  • Willingness and ability to comply with scheduled visits and all study related procedures.
  • 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
  • Metavir fibrosis stage 1, 2 or 3 as assessed by liver biopsy performed a maximum of 6 months prior to the Screening visit.
  • 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 Criteria20

  • Metavir fibrosis stage 0 or 4 assessed by liver biopsy
  • Evidence of liver disease caused by aetiology other than HCV, including alcohol.
  • Liver Transplant for HCV end stage liver disease less than 12 months prior to study screening visit.
  • Decompensated severe liver disease.
  • HCC or suspicion of HCC clinically or on ultrasound
  • Presence of HIV
  • HBV co-infection
  • EBV co-infection
  • Autoimmune disease history
  • ALT < 1.5 x ULN last visit prior to Baseline visit.
  • Renal impairment (creatinine >1.5ULN) or hepatorenal syndrome.
  • Pancreatitis
  • Ribavirin/Interferon concurrent treatment
  • Alcohol consumption history (M:> 21 drinks/week; F: 14 drinks/week)
  • Body Mass Index (BMI) > 27.5kg/m squared.
  • History of Type II Diabetes
  • Pregnant women - positive BHCG
  • patients with eGFR < 30mL/min
  • MRI contraindication
  • gadolinium contrats agent intolerance or contra-indication (as per the RANZCR guidelines Jan 2008).
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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 HC

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)).

Locations(1)

Australia

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ACTRN12612000357853