Proton Density Fat Fraction MRI to estimate liver iron content

Comparing estimation of liver iron load between Ferriscan(TM) and Proton Density Fat Fraction (PDFF) by magnetic resonance imaging, in patients with hyperferritinaemia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000186257

Enrollment

Registered

2018-02-05

Start date

2017-09-07

Completion date

2018-08-01

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Healthy volunteers

Inclusion criteria

Elevated serum ferritin level > 500ug/L (as repeated a second time by a central diagnostic laboratory after 4 weeks)

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

Outcome results