RecruitingACTRN12618000186257

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


Sponsor

The Canberra Hospital

Enrollment

40 participants

Start Date

Sep 7, 2017

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of MRI scans to see how well each one can measure the amount of iron stored in the liver. Having too much iron in the liver can cause organ damage and needs to be monitored. The study compares a newer, less expensive technique called Proton Density Fat Fraction MRI (PDFF) against a more expensive but well-established test called Liver FerriScan. If the cheaper test works just as well, doctors may be able to use it more widely to monitor patients with high iron levels. You may be eligible if: - You have a confirmed high blood ferritin level (above 500 µg/L on two tests taken 4 weeks apart) You may NOT be eligible if: - There are other possible causes of high ferritin that have not yet been investigated (e.g. infection or cancer) - You have a condition that prevents you from having an MRI (e.g. claustrophobia, pacemaker, or metal implants) - You have a terminal illness with a life expectancy of less than 3 months Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

The Canberra Hospital - Garran

ACT,NSW, Australia

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ACTRN12618000186257