FerriSmart

Automated MRI Measurement Of Liver Iron Concentration

FerriSmart is an automated system for measuring liver iron concentration (LIC). FerriSmart uses a specially trained convolutional neural network (artifical intelligence – machine learning) to analyse R2-MRI images to quantify the patient’s LIC.  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. 

In addition to FerriScan, FerriSmart is the only FDA approved MR companion diagnostic for use with deferasirox. 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 reproducible, and reliable results.

Once acquired, these images are uploaded to the FerriSmart neural network via web portal or through verified channel partners. FerriSmart delivers analysis results virtually instantaneously, with a report delivered directly back to the clinician and patient in real-time. FerriSmart offers a fully integrated and automated analysis service. 

The reliability of FerriScan and FerriSmart provide clinicians with data required to optimize patient treatment based on their actual level of liver iron overload. 

FerriSmart has been trained on thousands of image datasets with LIC measured using the FDA cleared, Gold standard FerriScan method. FerriSmart has been validated on image datasets from 77 different MRI scanners (including Siemens, Philips, and GE models)

  • Simple upload of DICOM files - select files, one click to analyse
  • FDA, CE Mark, and TGA regulatory clearances
  • Stringent Input quality control checks to ensure data quality
  • Real time analysis and instant LIC report generation, less than 30 seconds to obtain results
  • Affordable and flexible service, ideal for in-house radiology reporting
  • Deployment available via cloud or locally

Key FerriSmart Features

  • FerriSmart provides an accurate, validated MRI-based measurement of liver iron concentration
  • FerriSmart is regulatory cleared by the FDA, TGA, and CE Mark
  • FerriSmart is non-invasive, requires no contrast agents and has a scan time of approximately 7 to 10 minutes
  • FerriSmart and FerriScan are the only FDA approved MR companion diagnostic for use with deferasirox.
  • FerriSmart has high sensitivity and specificity for measuring LIC across the full range of iron loading
  • FerriSmart has been trained on thousands of image datasets with LIC measured using the FDA cleared, CE marked FerriScan method
  • FerriSmart can measure LIC over the entire range encountered in clinical practice
  • FerriSmart results are clinically validated to be unaffected by inflammation, fibrosis or cirrhosis
  • FerriSmart requires no breath-hold and may therefore be used for paediatric patients
  • Results are accurate, reliable, instantaneous,and reproducible over time and between MRI centres and models of scanner
  • Increased efficiency for via full integration into radiology workflows, automated solution with real-time turn-around
  • FerriSmart is suitable for 1.5 Tesla MRI scanners

Advantages of FerriSmart over serum ferritin (SF)

  • Other factors present in patients with iron overload such as infection, inflammation, fever, cancer, metabolic disease, or liver damage may result in significant elevation of serum ferritin concentrations in the absence of iron overload;
  • SF has poor accuracy for measuring body iron loading in patients with thalassaemia major;
  • SF levels in patients with thalassaemia intermedia are significantly lower than in patients with thalassaemia major despite them having comparable Liver Iron Concentration (LIC) levels (as determined by biopsy), suggesting that SF significantly underestimates iron loading in patients with thalassaemia Intermedia;
  • Increased serum ferritin concentrations may indicate iron overload, but are not a quantitative measure of iron burden. Additionally, once SF becomes saturated, there is poor correlation between SF and iron levels;
  • SF is an imprecise and potentially misleading parameter on which to base clinical management decision in patients with sickle cell disease (SCD);
  • The relationship between total body iron stores and SF in patients with hereditary haemochromatosis is very weak;
  • SF has significant limitations in assessment of iron burden in children with SCD, and liver iron assessment therefore is necessary for optimal management.

Advantages of FerriSmart over liver biopsy

  • Non-invasive, painless, no risk of bleeding or infection;
  • Cost is significantly lower than biopsy;
  • FerriSmart measures iron in a volume of liver that is thousands of times greater than liver biopsy and therefore potentially has a much smaller sampling error;
  • Sample size of the biopsy specimen only represents 1/50,000th of the total mass of the liver, therefore the sampling error is potentially large - the location where the biopsy is taken from will affect the result, and may not be representative of the entire liver.

Advantages of FerriSmart over Liver T2* (MRI)

  • There are a number of liver T2* techniques and these are not standardised. Non standardisation means that it is very difficult to compare results. See Graph below;
  • The liver T2* techniques are not regulatory cleared;
  • As a patient’s LIC starts to climb, the liver T2* techniques become more unreliable and eventually fail at higher iron levels. This can occur from 15 mg/g dry weight (depending on method of acquisition and analysis);
  • The liver T2* methods do not report across the full range of iron loading seen in clinical practice. (Published liver T2* methods measured LICs up to 23.6, 27.67 and 32.98 mg/g dry tissue, respectively.);
  • The liver T2* techniques can be influenced by the presence of liver fat and fibrosis;
  • A review of the literature shows that, unlike FerriSmart R2-MRI, liver T2* methods generate data that are scanner and method dependent and hence are not sufficiently standardised to enable reliable liver iron concentration measurements using calibration curves published from other centres;
  • Liver T2* to LIC conversion is dependent on a number of factors including various scanning profiles, various methods of analysis, and which calibration curve is used. The variance in several T2* techniques can be seen in the tables below. For the purposes of comparison, the LIC result derived from a calculated liver T2* value of 2.5ms will vary widely depending on which calibration curve has been used for conversion (see red line on Graph below).

Graph shows various Liver T2* conversions to LIC.

FerriSmart via Resonance Health

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.

The entire FerriSmart analysis process is completely automated.  The FerriSmart technology will initially inspect all images to ensure that they have been acquired with the correct protocol.  If errors are detected in the method of data acquisition, FerriSmart will not analyse the data but will indicate the corrective steps that need to be taken to acquire compliant images.  If no data acquisition errors are detected, FerriSmart automatically chooses the optimum slice for analysis, measures the mean liver iron concentration in that slice, and produces a liver iron concentration report that can be saved as a PDF file or printed out for patient records.  Uploading and analysis of data typically takes about 30 seconds.

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.

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FerriSmart Testimonials

“Serum ferritin generally correlates with total body iron stores. However, predictive value of serum ferritin is quite poor and patients with identical SF can have highly variable body iron burden. Further, change in liver iron may not be predicted accurately enough from ferritin measurements. Over reliance to serum ferritin trends may lead to inappropriate management decisions and inaccurate conclusions regarding patient adherence for iron chelation therapy. Because of that, monitoring patients' body iron burden by MRI measured liver iron concentration has been the standard of care in iron overloaded patients. 

Prof. Dr. Yesim Aydinok
Ege University Hospital, Department of Pediatric Hematology Director of Hospital Blood Bank

“In our Radiology department we are using FerriSmart for measurement of liver iron concentration. The set up and acquisition of the images for FerriSmart is easy. We upload the images to the system and receive the report  immediately. It is quite practical. Previously we had a manual measurement programme and measurement of each patient took approximately 10-15 minutes which was a great workload for us. FerriSmart has increased our productivity, we can reach more thalassemia patients now.”

Assoc. Prof. Dr. Selen Bayraktaroglu
Ege University Hospital, Radiology Department

“FerriSmart is easy to use, just upload data then wait a few second for the result.  Access to the result is simple, with quick service support.”

Dr Trang Nguyen Ngoc
Senior Radiologist Bach Mai Hospital, Vietnam Department of Radiology BMH

FerriSmart Resources

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