Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000025831
Ethics application status
Not yet submitted
Date submitted
4/01/2012
Date registered
6/01/2012
Date last updated
1/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
HepaFatTM Scan for the non-invasive measurement of liver fat using magnetic resonance imaging
Scientific title
For patients with liver disease, is HepaFat Scan as accurate (ie has equal or better sensitivity and specificity) as liver biopsy for measuring liver fat?’
Secondary ID [1] 279660 0
Nil
Universal Trial Number (UTN)
U1111-1126-7841
Trial acronym
NIMFat
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic fatty liver disease (NAFLD) 285469 0
Hepatic steatosis 285470 0
Condition category
Condition code
Metabolic and Endocrine 285651 285651 0 0
Other metabolic disorders
Oral and Gastrointestinal 285652 285652 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
HepaFat Scan is a magnetic resonance (MR) image analysis product to facilitate the non invasive quantification of fat within the liver.

The technology is based on gradient recalled echo imaging using the technique of Dixon et al. However, several novel changes have been made to this established method to enable HepaFat Scan to provide greater degrees of sensitivity and specificity in measuring liver fat than other available methods.

This will be a retrospective study using existing demographic, clinical and MRI image data (obtained between March 2009 and December 2011 and available in institutional databases) from 10 subjects without liver disease (healthy controls) and up to eighty (80) patients with liver disease. Neither patients nor healthy control subjects are required to undergo any additional procedures or MRI scans.
Intervention code [1] 283941 0
Not applicable
Comparator / control treatment
Each study participant will have undergone an MRI scan to acquire the image data required for HepaFat Scan as well as a liver biopsy as part of a previous study. The amount of fat that is shown to be present in the liver using the results from HepaFat Scan will be compared to the results of the liver biopsy.
Control group
Active

Outcomes
Primary outcome [1] 286204 0
To measure the diagnostic performance of HepaFat Scan to grade liver fat when a histopathologist's visual assessment of liver biopsy specimens is used as the reference standards.
Timepoint [1] 286204 0
Baseline
Secondary outcome [1] 295384 0
To measure the diagnostic performance of HepaFat Scan to grade liver fat when a reference standard based on quantitative computer assisted morphometric image analysis of histological sections is used instead of a histopathologist's visual assessment.
Timepoint [1] 295384 0
Baseline

Eligibility
Key inclusion criteria
Age 18-65 years
Confirmed diagnosis of liver disease
Liver biopsy within 12 months prior to entry into the study
Alcohol consumption <20 grams/day for men and <10 grams/day for women.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to provide informed consent
Contraindications for MRI
Ischemic heart disease as determined by history or abnormal ECG.
Pregnancy or lactation.
Malignancy (excluding basal cell or squamous cell skin cancers)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284440 0
Commercial sector/Industry
Name [1] 284440 0
Resonance Health Analysis Services Pty Ltd
Country [1] 284440 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Resonance Health Analysis Services Limited
Address
PO Box 1135
Nedlands, Western Australia, 6909
Country
Australia
Secondary sponsor category [1] 283363 0
None
Name [1] 283363 0
Address [1] 283363 0
Country [1] 283363 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286418 0
Ethics committee address [1] 286418 0
Ethics committee country [1] 286418 0
Date submitted for ethics approval [1] 286418 0
13/01/2012
Approval date [1] 286418 0
Ethics approval number [1] 286418 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33240 0
Address 33240 0
Country 33240 0
Phone 33240 0
Fax 33240 0
Email 33240 0
Contact person for public queries
Name 16487 0
Helen Pavitt
Address 16487 0
Resonance Health Analysis Services Pty Ltd
PO Box 1135
Nedlands, Western Australia, 6909
Country 16487 0
Australia
Phone 16487 0
+61 8 9286 5300
Fax 16487 0
+61 8 9286 1179
Email 16487 0
helenp@resonancehealth.com
Contact person for scientific queries
Name 7415 0
Helen Pavitt
Address 7415 0
Resonance Health Analysis Services Pty Ltd
PO Box 1135
Nedlands, Western Australia, 6909
Country 7415 0
Australia
Phone 7415 0
+61 8 9286 5300
Fax 7415 0
+61 8 9286 1179
Email 7415 0
helenp@resonancehealth.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.