FerriScan® provides an accurate measurement of liver iron concentration (LIC) through a non-invasive, MRI-based technology. The measurement is performed in a central Service Centre and provided via our unique Quality Assured Service Delivery model.
FerriScan® was regulatory cleared by the FDA for the measurement of LIC in 2005. In January 2013 FerriScan gained an additional clearance from the FDA as a companion diagnostic to aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox. FerriScan is internationally recongized as the gold standard in liver iron concentration (LIC) measurement.
The FerriScan process uses patented R2-MRI imaging technology. Acquired magnetic resonance images are securely transmitted to the Resonance Health Service Centre. The patented FerriScan analysis procedure produces a mean LIC measurement and a colour coded map reflecting the iron distribution across the liver.
FerriScan analysis provides proven accuracy in the determination of liver iron concentration and has the highest sensitivity and specificity over the range of liver iron concentrations of any MRI-based method of LIC measurement. Results that are reliable and reproducible over time and across different models of MRI scanner.
FerriScan was originally calibrated against liver biopsy in 105 patients with various iron overload conditions. A further multi-centre validation study on five different scanners with 233 patients concluded:
- The FerriScan technique is robust
- There is no shift in accuracy or precision across different MRI scanners
- FerriScan is unaffected by fibrosis or chelation therapy
- FerriScan can be used with patients of all ages
FerriScan is recommended in multiple clinical patient management guidelines. More recently, iron overload is becoming increasing recognised as a complication in cancer survivors who received multiple blood transfusions as part of their cancer therapy. To read more about the application of FerriScan in this setting please refer here: Iron Overload in Cancer Survivors.
Key FerriScan Features
- FerriScan provides an accurate, validated MRI-based measurement of liver iron concentration
- FerriScan is regulatory cleared by the FDA, TGA, and CE Mark
- FerriScan is non-invasive, requires no contrast agents and has a scan time of approximately 10 minutes
- FerriScan has high sensitivity and specificity for measuring LIC
- Image analysis and LIC reporting is performed at a central ISO 13485 certified Service Centre
- FerriScan has international regulatory clearance and approvals (USA, Europe, Australia)
- Results are available within a target time of two business days
- FerriScan can measure LIC over the entire range encountered in clinical practice
- FerriScan results are clinically validated to be unaffected by inflammation, fibrosis or cirrhosis
- FerriScan requires no breath-hold and may therefore be used for paediatric patients
- Results are accurate, reliable and reproducible over time and between MRI centres and models of scanner
- There is no requirement for customers to purchase new software or hardware, resulting in minimal training requirements
- FerriScan is suitable for 1.5 Tesla MRI scanners
- FerriScan is charged per scan only
To see more information, view the FerriScan Fact Sheet.
Why Use FerriScan R2-MRI to Measure Liver Iron Concentration?
FerriScan is quick, easy and painless, with an MRI scan time of only ten minutes. FerriScan does not require any contrast agents and being MRI based there is no risk from radiation.
The accurate Liver iron Concentration (LIC) measurement can be used by clinicians to monitor iron loading and adjust treatment regimes accordingly.
FerriScan provides a more accurate and reliable measure of LIC at any point in time than that provided by serum ferritin and patients need no longer undergo the painful, time consuming process of liver biopsy.
Unlike liver biopsy, which provides an analysis of LIC in only one small area, FerriScan analyses a cross-section of the liver. This area is typically thousands of times larger than biopsy, hence significantly reducing the biopsy sampling error.
The analysis of data by trained experts within a quality-controlled environment eliminates issues of inter-observer variability.
FerriScan is being used by clinicians in over 45 countries worldwide to aid their diagnosis, management and monitoring of iron overload.
FerriScan is a solution with proven value in improving the health outcomes of patients suffering from diseases such as thalassaemia, sickle cell disease, haemochromatosis and myelodysplastic syndrome.
From a Clinician’s Perspective
Dr Josu de la Fuente, Consultant Paediatric Haematologist and Senior Lecturer at Imperial College London and Director of the Paediatric Blood and Marrow Transplant Programme, speaks about the clinical benefits of FerriScan:
FerriScan is included in the routine treatment protocols for Thalassaemia at the Imperial College Healthcare. For example, information about Thalassemia and evidence for the use of FerriScan in paediatric management is included in the following protocol:
Additional FerriScan Information for Clinicians
Frequently Asked Questions
A number of case studies referencing FerriScan have been published by centres of excellence:
Use of FerriScan in Disease Management
FerriScan provides the clinician with:
- A baseline measurement of the precise concentration and distribution of iron in the liver
- Assistance in providing a definitive iron overload diagnosis
- The ability to optimise treatment based on the level of iron loading; thereby enabling positive treatment outcomes
Use of FerriScan in Iron Overload Management Protocols
- Iron Overload Assessment and Monitoring Protocol
- Myelodysplastic Syndrome Protocol
- Paediatric Thalassaemia Disorders
Iron Overload Information and Evidence of FerriScan Use (Presentations)
Scientific Evidence in Iron Overload Measurement
Resonance Health has developed a reputation for the highest standards of scientific rigour, which is underpinned by our company-wide commitment to quality and continuous improvement.
FerriScan has been validated by international regulatory authorities and is widely used by major pharmaceutical companies in clinical trial settings.
A number of scientific publications have provided evidence for the use of FerriScan in clinical management of iron overload conditions.
- FerriScan Scientific Publications List
- Noninvasive measurement and imaging of liver iron concentrations using proton magnetic resonance
- Why Use FerriScan® R2-MRI to Measure Liver Iron Concentration?
- Why is FerriScan Superior to other tests in the estimation of body iron loading?
- Performance and Limitations of R2*/T2* Relaxometry Liver Iron Measurements
FerriScan: Patient Management Guidelines
An increasing number of patient treatment guidelines for thalassaemia, sickle cell disease, myelodysplastic syndrome and haemochromatosis recommend using MRI to quantitatively measure liver iron concentration.
For a compiled list of treatment guidelines involving R2 MRI (FerriScan), please click here.