COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Proton Density Fat Fraction MRI to estimate liver iron content
Scientific title
Comparing estimation of liver iron load between Ferriscan(TM) and Proton Density Fat Fraction (PDFF) by magnetic resonance imaging, in patients with hyperferritinaemia
Secondary ID [1] 293921 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acquired iron overload 306408 0
hereditary haemochromatosis 306409 0
disorders of red cell metabolism 306410 0
non-alcoholic fatty liver disease 306411 0
alcoholic fatty liver disease 306412 0
Condition category
Condition code
Metabolic and Endocrine 305498 305498 0 0
Other metabolic disorders
Diet and Nutrition 305499 305499 0 0
Other diet and nutrition disorders
Blood 305500 305500 0 0
Human Genetics and Inherited Disorders 305541 305541 0 0
Other human genetics and inherited disorders

Study type
Description of intervention(s) / exposure
Blood testing, as routinely already performed, may need to be repeated at ACT Pathology to confirm through a centralised technique, the magnitude of hyperferritinaemia. No other additional blood tests are required for participating in this study, however the treating doctor may have already recommended additional tests in order to try to investigate the hyperferritinaemia. Any relevant data here may be collected by the study investigators.

MRI scanning involves a single presentation to the radiology facility where both the Ferriscan(TM) and the PDFF scan will be performed. In total this takes approximtely 20 minutes. The MRI technologist will perform this procedure for you.

The results of the MRI scans will be forwarded to your treating doctor who will then discuss these results with you.
Intervention code [1] 300191 0
Diagnosis / Prognosis
Comparator / control treatment
Liver iron estimate via Ferriscan(TM) constitute the control
Control group

Primary outcome [1] 304629 0
Liver iron content correlation of study MRI (PDFF) vs gold standard MRI (Ferriscan)
Timepoint [1] 304629 0
Immediately after the MRI scanning is performed
Secondary outcome [1] 342629 0
Impact of PDFF results on clinical decision making regarding referrals of patients with hyperferritinaemia via a questionnaire designed specifically for this study, and presented to the referring clinicians that are investigating the patient with hyperferritinaemia
Timepoint [1] 342629 0
Immediately after follow up consultation with the treating referring doctor, and once the radiology results are available

Key inclusion criteria
Elevated serum ferritin level > 500ug/L (as repeated a second time by a central diagnostic laboratory after 4 weeks)
Minimum age
No limit
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Clinically relevant investigations to explore alternative causes for hyperferritinaemia pending (e.g. chronic infection, malignancy etc when clinically deemed appropriate)
2. Any contraindication to MRI scanning including claustrophobia, and incompatible indwelling metallic implants
3. Terminal illness with a life expectancy less than 3 months

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Pearson's correlation for performance between PDFF vs Ferriscan (TM)

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 9923 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 18732 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 298550 0
Commercial sector/Industry
Name [1] 298550 0
Novartis Australia
Address [1] 298550 0
54 Waterloo Road, Maquarie Park, NSW 2113
Country [1] 298550 0
Primary sponsor type
The Canberra Hospital
Yamba Drive, Garran, ACT 2605
Secondary sponsor category [1] 297697 0
Name [1] 297697 0
Address [1] 297697 0
Country [1] 297697 0

Ethics approval
Ethics application status
Ethics committee name [1] 299519 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 299519 0
The Canberra Hospital
Ethics committee country [1] 299519 0
Date submitted for ethics approval [1] 299519 0
Approval date [1] 299519 0
Ethics approval number [1] 299519 0
ETH.1.17.016 - HREC/17/ACT/3

Brief summary
This project aims to evaluate the results of a relatively inexpensive, noninvasive Liver MRI using an algorithm called “Proton Density Fat Fraction MRI (PDFF)” which uses “multi-peak spectral modelling and R2*”, and compare them against an alternative, more expensive technology called “Liver Ferriscan®” (Resonance Health, Western Australia), which is accepted as a reference standard for determining liver iron content.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 80698 0
Dr Philip Choi
Address 80698 0
Level 5, Canberra Region Cancer Centre
The Canberra Hospital
Yamba Drive, Garran ACT 2605
Country 80698 0
Phone 80698 0
Fax 80698 0
Email 80698 0
Contact person for public queries
Name 80699 0
Dr Philip Choi
Address 80699 0
Level 5, Canberra Region Cancer Centre
The Canberra Hospital
Yamba Drive, Garran ACT 2605
Country 80699 0
Phone 80699 0
Fax 80699 0
Email 80699 0
Contact person for scientific queries
Name 80700 0
Dr Philip Choi
Address 80700 0
Level 5, Canberra Region Cancer Centre
The Canberra Hospital
Yamba Drive, Garran ACT 2605
Country 80700 0
Phone 80700 0
Fax 80700 0
Email 80700 0

No information has been provided regarding IPD availability
Summary results
No Results