Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000186257
Ethics application status
Approved
Date submitted
31/01/2018
Date registered
5/02/2018
Date last updated
5/02/2018
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
None
Universal Trial Number (UTN)
U1111-1208-7518
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
Anaemia
Human Genetics and Inherited Disorders 305541 305541 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Diagnosis
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pearson's correlation for performance between PDFF vs Ferriscan (TM)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/09/2017
Date of last participant enrolment
Anticipated
1/08/2018
Actual
Date of last data collection
Anticipated
1/08/2018
Actual
Sample size
Target
40
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
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
Country [1] 298550 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Yamba Drive, Garran, ACT 2605
Country
Australia
Secondary sponsor category [1] 297697 0
None
Name [1] 297697 0
Address [1] 297697 0
Country [1] 297697 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 299519 0
06/02/2017
Approval date [1] 299519 0
27/04/2017
Ethics approval number [1] 299519 0
ETH.1.17.016 - HREC/17/ACT/3

Summary
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

Contacts
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
Australia
Phone 80698 0
+61261748514
Fax 80698 0
+61261745544
Email 80698 0
[email protected]
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
Australia
Phone 80699 0
+61261748514
Fax 80699 0
+61261745544
Email 80699 0
[email protected]
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
Australia
Phone 80700 0
+61261748514
Fax 80700 0
+61261745544
Email 80700 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

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

Documents added automatically
No additional documents have been identified.