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 example:
The Cooley's Anemia Foundation (USA) 2010 Position Statement
“The Cooley’s Anemia Foundation supports research and medical advancements for patients and their families. To this end, the Foundation supports the use of MRI methods, as important, patient-friendly alternatives to liver biopsy.Among the published MRI methods for iron detection in patients with transfusional (and non-transfusional) iron overload, Ferriscan is unique because of regulatory approval in several countries.
FerriScan and other MRI iron assessment methods provide a non-invasive and cost-effective means to monitor liver iron concentration in transfused patients with thalassemia, sickle cell disease and other blood disorders as well as patients with hemochromatosis.
FerriScan is an MRI-based technology capable of accurately measuring liver iron concentrations in all patients regardless of the amount of iron in their liver, a feature particularly important for patients with heavy iron loading often found with thalassemia. Some of the other MRI-based methods are less accurate at higher iron concentrations.The Cooley’s Anemia Foundation believes that MRI iron assessments, including FerriScan, should be available to all patients who rely on iron overload measuring to identify excess iron which accumulates in the liver and which leads to serious complications such as liver fibrosis and organ failure. Regular monitoring of liver iron can improve the management of iron overload leading to prolonged and improved quality of life. There is significant clinical and scientific evidence available to support this technique as a means to monitor liver iron concentrations in patients with thalassemia.
MRI based iron assessment represents the type of medical breakthrough our members depend on. Ferriscan itself is a high-quality (clinical grade, FDA approved) method of accomplishing this assessment.”
The 2008 “Guidelines for the clinical management of Thalassaemia” (updated 2nd edition), written by the Thalassemia International Federation (TIF) states:
“LIC can also now be measured using MRI techniques, previously limited to a relatively narrow linear range. One recently described approach, is the R2 or FerriScan technique which appears to have acceptable linearity and reproducibility over the range of clinical interest (St Pierre TG, et al, 2005). The technique demonstrates an average sensitivity of >85% and specificity of >92% up to an LIC of 15 mg/g dry wt, and has been registered in the EU and US. For calibration, the MRI machine must use a Phantom supplied by the company, while the data acquired is sent via internet for analysis by dedicated FerriScan software (payment per scan analysed). A particular advantage of this technique is that it can be applied with little training, at any centre with a reasonably up-to-date MRI machine”.
The Italian Society of Hematology Practice Guidelines published in 2008 state:
“Nine studies of at least 10 thalassemic patients that evaluated the accuracy of measurement of LIC by MRI, and included a quantitative measurement of MRI signal and a detailed description of the patient population were selected. Strong linear correlations (R2=approximately 1.0) were demonstrated in four studies. The best result was obtained with the R2 methodology which resulted in a curvilinear relationship between R2 and LIC by biopsy over the entire clinically relevant range of LICs” and “evidence of the accuracy of non-invasive methods for assessment of liver iron concentration is sufficient to recommend MRI technology as a feasible alternative to liver biopsy. R2 sequences and individual local calibration are recommended”.
The “Standards for the clinical care of children and adults with Thalassaemia in the UK” published by the UK Thalassaemia Society in 2008 (2nd edition) states:
“All patients should have access to MRI modalities (Cardiac T2* MRI and either R2 or T2* of liver) for monitoring myocardial and liver iron. MRI is an attractive alternative for liver iron estimation since magnetic relaxation times are sensitive to tissue iron levels. The R2 (1/T2) technique (Ferriscan®) has been registered in the European Union, and can be done on a standard MRI scanner, with data sent electronically to a commercial organization for analysis (St. Pierre et al 2005). The T2* technique has the advantage that it can be done at the same time as the T2* cardiac scan (Anderson et al 2001) but is probably less accurate in measuring liver iron levels.”
The “Standards for the clinical care of adults with sickle cell disease in the UK” published by the UK Sickle Cell Society in 2008 (1st edition), states:
“All patients who have been previously transfused or are currently undergoing regular transfusions, whether top-up or exchange, should have regular quantitative monitoring of liver iron concentration using MRI”.
The Nursing Practice Guideline: Care of the patients with sickle cell disease and iron overload, published by the International Association of Sickle Cell Nurses and Physician Assistants in 2008 states:
“Effective management of iron overload begins with frequent assessment of iron burden. Ideally this should be a quantitative method of iron measurement which is safe, effective and provides a high level of accuracy.” It lists FerriScan as achieving these criteria and thus is a suitable method for measuring LIC.
Wells and colleagues state in their publication from 2008 “Iron overload in myelodysplastic syndromes: a Canadian consensus guideline”:
“The most accurate and precise MRI technique for measurement of LIC was developed by St. Pierre et al., who found mean liver proton relaxation rates (R2) correlated strongly with LIC, as determined by biopsy across a broad range of LIC values.”
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