FerriScan for Patients
Frequently Asked Questions
When the body absorbs more iron than is required in normal daily usage, it has no natural mechanism to remove the excess iron. This may happen as a result of the body absorbing too much iron through the diet or where additional iron is introduced through regular blood transfusions in the treatment of disease. Surplus iron accumulates in the organs and tissues of the body, particularly the liver, potentially leading to liver fibrosis, liver cancer and death. Most cases of iron overload are the result of genetic conditions such as Thalassaemia, Sickle Cell Disease or Hereditary Haemochromatosis.
Liver fibrosis is scarring of the liver. Like any other scars, this indicates that some damage has occurred. If the cause of the fibrosis is identified and early treatment provided, it is often possible for the damage to be reversed, otherwise further liver complications may ultimately occur.
If your doctor suspects that you have iron overload, an initial serum ferritin test will be ordered by your doctor. The results of this will indicate whether you have high levels of serum ferritin in your body. However, serum ferritin is only a surrogate marker for total body iron stores and can be affected by other conditions such as alcohol consumption, metabolic syndrome, obesity, diabetes, liver disease, malignancy, infection or inflammation. In addition serum ferritin saturates at higher liver iron concentrations, meaning that it is not useful to quantify iron overload. Therefore, it cannot be used alone for the diagnosis and clinical management of iron overload.
So what are the alternatives when a serum ferritin test result is high? Prior to FerriScan and FerriSmart, which are R2-MRI based techniques for the quantification of liver iron concentration, the gold standard (or accepted ‘best practice’) method for estimating the extent of iron loading in the liver was through liver needle biopsy, which is an invasive and unpleasant surgical procedure. The need for anesthesia, patient monitoring and recovery time also makes it expensive. In addition, when a biopsy is taken, the sample size is only a very small fraction (1/5000) of the liver, which is subject to large sampling error for assessing liver iron levels, especially when the liver iron distribution is varied throughout the liver.
There are also several MRI-based methodologies known as T2* or Signal Intensity Ratio (SIR) that may be used to provide a T2* value and attempt to equate this to a liver iron concentration. There is a fundamental limitation of the T2* methods that causes them to fail at high liver iron concentrations. This, combined with the variability in results between different scanners and MRI centres, reduces significantly the reliability of these methods. Additionally, these tests fail to offer the standardization and quality control systems offered by the FDA-cleared MRI-based products FerriScan and FerriSmart.
Magnetic Resonance Imaging (MRI) is a technology that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body. In many cases, MRI gives different information about structures in the body than can be seen with an X-ray, ultrasound, or computed tomography (CT) scan.
An MRI scan allows detailed information to be gathered about the body’s organs without the need for invasive surgical procedures such as liver biopsy. The FerriScan images show an entire cross-section of the liver and allow a more accurate evaluation of the liver as compared to liver biopsy.
FerriScan is an MRI-based, non-invasive test for the measurement of Liver iron Concentration (LIC) in patients who may be suffering from liver iron overload. FerriScan, which was originally calibrated against liver biopsy, is now considered the gold-standard in the measurement of LIC, has been established in over 450 prestigious hospital centres across the globe, and is included in numerous international clinical guidelines. It has been used by both leading clinicians and pharmaceutical companies in trials of new medications for over 15 years.
FerriSmart is a stand-alone software application that automatically analyses MRI (DICOM) images that are uploaded via the FerriSmart web portal. These images, acquirable on most makes and models of 1.5 Tesla MRI machines, are obtained through a unique and standardized scanning sequence to ensure results are accurate, reliable, and reproducible over time and between hospitals and the various makes and models of MRI scanners. Upon the automated analysis, a Liver Iron Concentration Report is delivered back to the MRI Centre (or Hospital) on-screen instantaneously Due to the quality-controlled, standardized nature of the test, a patient may have a FerriSmart at any FerriSmart-verified MRI centre, anywhere in the world, and receive accurate, reliable results.
FerriScan is an image analysis service that can be established on most makes and models of 1.5 Tesla magnetic resonance imaging scanners at MRI centres around the world. These centres are given a set of instructions (the FerriScan protocol) to adjust their scanner’s settings so that it can collect FerriScan images correctly. Abdominal (mid-section) images are captured by the scanner and uploaded to a secure server at Resonance Health’s central Service Centre. This data is processed by trained analysts using the patented FerriScan software under a quality-controlled system. A Liver Iron Concentration (LIC) Report is delivered back to the MRI Centre within two business days. It includes:
- The patient’s Liver Iron Concentration;
- A table to indicate the clinical relevance of their LIC measurement;
- A map of the iron distribution across their liver;
- A histogram showing indicative iron distribution;
- Where available, historical data showing the patient’s progress over time.
The report is then sent to the referring clinician to help them confirm the patient’s diagnosis and develop their treatment plan. Due to the quality-controlled, standardized nature of the test, a patient may have a FerriScan at any FerriScan-verified MRI centre, anywhere in the world, and receive accurate, reliable results.
Ask your doctor if you need a FerriScan to measure your LIC and if there is a local radiology centre that offers the service. Further information can be obtained by contacting us at Resonance Health via firstname.lastname@example.org
No. MRI works using electro-magnetic energy, not radiation, so it is safe for people of all ages to have a FerriScan as and when required. There are some restrictions associated with MRI use, such as in pregnancy or in people who have metal implants, but these will be discussed with patients by the MRI technicians beforehand.
Being non-invasive, FerriScan is a painless test. Some people may experience anxiety in an MRI scanner as it can be noisy and can feel a little claustrophobic, however MRI technicians are very experienced at putting patients at their ease.
FerriScan has the following regulatory clearances:
- In the USA by the FDA (Food and Drug Administration);
- In Australia by the TGA (Therapeutic Goods Administration);
- In Europe (CE Mark). which covers 27 countries.
FerriScan is suitable for patients of all ages. Because it is non-invasive, it is painless and can be used repeatedly. It does not require a contrast agent or a breath-hold. This means that very young patients who may required some sedation to keep still enough for an MRI scan can also successfully have a FerriScan.
People who have had serum ferritin tests that indicate they may have high levels of body iron, especially if they have:
- A disease that is likely to lead iron overload;
- Repeated blood transfusions;
- A genetic predisposition to absorb excessive amounts of iron
FerriScan has a 7 to 10 minute scan time. Results are then analysed and returned to the MRI Centre within a target time of two business days.
No medication is required before this test.
- Patient information can be seen on the first page at the top of the report.
- On the front page, liver iron concentration results are displayed in the square boxbelow the patient information. In this report, the 6.8mg/g dry tissue indicates the average LIC of the patient. This 6.8 mg/g dry tissue and its clinical relevance can be seen in the FerriScan report and in the table below.
- When applicable, the history page is included to provide a patient with their LIC changes over time. This is tracked on the LIC Historic Plot graph, and as a value in the adjacent table.
- Patient information can be seen at the top of the report;
- The QR code (top right of report) provides patients and clinicians with a way to authenticate FerriSmart reports. In some countries, because FerriScan is a very well-known test, sometimes patients may be told they ‘have had a FerriScan’ as a general to describe a liver MRI, however not all MRI-based tests are equal;
- Liver iron concentration results are displayed in the square box. In this report, the 10.0mg/g dry tissue indicates the average LIC of the patient. This 10.0mg/g dry tissue and its clinical relevance can be seen in the question ‘What does my FerriScan result mean?’ below.
The below table shows the LIC thresholds in Transfusional Iron Overload, and their clinical relevance.