Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000357853
Ethics application status
Approved
Date submitted
5/12/2011
Date registered
28/03/2012
Date last updated
28/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
PUMA: A pilot study to assess the utility of magnetic resonance imaging in the staging of liver fibrosis.
Scientific title
PUMA: A pilot study to assess the utility of magnetic resonance imaging in the staging of liver fibrosis.
Secondary ID [1] 262350 0
'None'
Universal Trial Number (UTN)
Trial acronym
PUMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with liver disease due to chronic hepatitis C virus (HCV) infection who have previously undergone a liver transplant (Group A) 268050 0
Condition category
Condition code
Infection 268192 268192 0 0
Other infectious diseases
Inflammatory and Immune System 268193 268193 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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)).
Intervention code [1] 266739 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266932 0
To assess the utility of MRI in the assessment and staging of liver fibrosis
Timepoint [1] 266932 0
1. Once at baseline (Visit 1 = Day 0)
2. Once at study completion (Visit 2 = 35-45 days post Visit 1)
Secondary outcome [1] 276649 0
To assess the within-patient reproducibility of MRI-derived fibrosis measurements
Timepoint [1] 276649 0
1. Once at baseline (Visit 1 = Day 0)
2. Once at study completion (Visit 2 = 35-45 days post Visit 1)
Secondary outcome [2] 295135 0
Explore the correlation between MRI-derived fibrosis measurements and:
a) Ishak fibrosis scores
b) Metavir fibrosis scores
c) Collagen proportionate area
d) FibroScan results
e) Liver function test results
Timepoint [2] 295135 0
1. Once at baseline (Visit 1 = Day 0)
2. Once at study completion (Visit 2 = 35-45 days post Visit 1)
Secondary outcome [3] 296778 0
Explore the sensitivity of MRI-derived fibrosis measurements to differentiate between ISHAK fibrosis stages 3 and 4.
Timepoint [3] 296778 0
1. Once at baseline (Visit 1 = Day 0)
2. Once at study completion (Visit 2 = 35-45 days post Visit 1)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5159 0
3084

Funding & Sponsors
Funding source category [1] 284330 0
Commercial sector/Industry
Name [1] 284330 0
Resonance Health Analysis Services
Country [1] 284330 0
Australia
Funding source category [2] 284960 0
Commercial sector/Industry
Name [2] 284960 0
Pfizer (Inc)
Country [2] 284960 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Resonance Health Analysis Services
Address
278 Stirling Highway
Claremont, Perth
Western Australia (WA) 6010
Country
Australia
Secondary sponsor category [1] 283273 0
Commercial sector/Industry
Name [1] 283273 0
Pfizer Inc
Address [1] 283273 0
Inflammation Research Group
200 Cambridge Park Drive
Cambridge
MA 02140
Country [1] 283273 0
United States of America
Other collaborator category [1] 260375 0
Other Collaborative groups
Name [1] 260375 0
Austin Health
Address [1] 260375 0
Liver Transplant Unit
Level 8, Harold Stokes Building (HSB)
Austin Hospital
Austin Health
Heidelberg VIC 3084
Country [1] 260375 0
Australia
Other collaborator category [2] 260666 0
Individual
Name [2] 260666 0
Professor Peter Angus
Address [2] 260666 0
Liver Transplant Unit
Level 8, Harold Stokes Building (HSB)
Austin Hospital
Austin Health
Heidelberg VIC 3084
Country [2] 260666 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286293 0
Austin Human Research Ethics Committee
Ethics committee address [1] 286293 0
Henry Buck Building
Austin Health
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 286293 0
Australia
Date submitted for ethics approval [1] 286293 0
20/01/2011
Approval date [1] 286293 0
13/04/2011
Ethics approval number [1] 286293 0
H2011/04178

Summary
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.
Trial website
Trial related presentations / publications
To Follow
Public notes

Contacts
Principal investigator
Name 32723 0
Address 32723 0
Country 32723 0
Phone 32723 0
Fax 32723 0
Email 32723 0
Contact person for public queries
Name 15970 0
Professor Peter Angus
Address 15970 0
Austin Hospital LTU
Level 8 HSB (Building)
Studley Road
Heidelberg VIC 3084
Country 15970 0
Australia
Phone 15970 0
+61 3 9496 5582
Fax 15970 0
+61 3 9496 3487
Email 15970 0
[email protected]
Contact person for scientific queries
Name 6898 0
Professor Tim St Pierre
Address 6898 0
Resonance Health Analysis Services Ltd
278 Stirling Highway
Claremont, Perth
WA 6010
Country 6898 0
Australia
Phone 6898 0
+61 412 229 113
Fax 6898 0
+61 8 9286 1179
Email 6898 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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