The LiverMultiScan can quantify liver fat, and is compatible with MRI devices.
A post-processing software device for multiparametric liver magnetic resonance imaging (MRI) has been approved by the US Food and Drug Administration (FDA).
The LiverMultiScan, from Perspectum Diagnostics, received 501(k) clearance from the FDA last week, allowing the cloud-based service to be implemented on compatible MR systems. It will serve to provide standardized, quantitative liver tissue measures in patients with liver disease.
The approval was announced the Radiological Society of North America (RSNA) conference last week.
Through non-invasive tissue characterization measures, the LiverMultiScan accurately quantifies liver fat — as well as T2 and iron-corrected T1, to gauge respective iron and fibro-inflammatory levels. The service does not require a contrast agent, and can be integrated into examinations from MRI devices including Siemens and Philips models.
The service is standardized across multiple manufacturers and field strengths, and enables clinicians to see heterogeneous liver disease without the need for additional hardware.
The LiverMultiScan also allows radiologists to complete a scan in 15 minutes per patient — or up to 4 scans every hour. It is available as a quantitative analysis service from Perspectum Diagnostics, with reports delivered as soon as 24 hours following scans.
In a study published in January 2014, researchers obtained MRI data in 79 patients using the service, to compare to invasive liver biopsy results from referred patients. The researchers used T1 mapping, proton spectroscopy, and T2 mapping to quantify liver fibrosis, steatosis, and haemosiderosis, respectively, in patients.
The study assessed associations between MR and histology variables, and receiver-operating characteristic analyses were also carried out.
There was a reported strong correlation in MR measures and histology among the 3 assessed conditions (Rs = 0.68, p<0.0001 for fibrosis; Rs = 0.89, p<0.001 for steatosis; Rs = -0.69, p<0.0001 for haemosiderosis).
Researchers concluded that the novel scanning service provides liver fibrosis, steatosis, and haemosiderosis assessments with high diagnostic accuracy, and could replace invasive liver biopsy for various indications. To their county, it was the first non-invasive test to demonstrate differentiated early stages of fibrosis from normal liver.
Non-alcoholic fatty liver disease (NAFLD), a cause of cirrhosis and liver failure, currently affects more than 30% of people in the US, and is growing in incidence due to obesity rates and unmet health care needs.
The study’s researchers pointed to alcohol-related liver disease, and viral hepatitis, as contributing conditions in an “epidemic of progressive liver disease and cirrhosis.”
Liver biopsy, once the “gold-standard” of diagnostic methods, is costly and carries a significant risk of serious bleeding in patients, researchers wrote.
“There is a pressing need for a reliable diagnostic tool to identify early stages of liver disease and to target therapies to those patients who may benefit from these,” researchers wrote.
Rajarshi Banerjee, PhD, lead author of the study and chief executive officer of Perspectum Diagnostics, said MRI is already a cornerstone in neurology, musculoskeletal medicine, and cardiology diagnostic pathways.
“We can now add liver disease to this list, taking us a step further on our journey towards establishing a replacement for more invasive diagnostic techniques for liver disease,” Banerjee said.
Mukesh Harisinghani, Abdominal Imaging and Interventional Radiologist at Massachusetts General Hospital, praised the utility of the LiverMultiScan.
“The development of standardized, robust methods for quantitative assessment of fatty liver disease is essential for both patients and physicians,” Harisinghani said. “LiverMultiScan is a useful radiological tool for clinical practice that will undoubtedly move the field forward and facilitate care of our patients with liver disease.”
The study, "Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease," was published online in Journal of Hepatology.
A press release regarding the approval was made available.