Frequently asked questions
Patients
What is Magnetic Resonance Imaging?
Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique which uses a powerful magnetic field and radio waves to produce details images of body organs or structures. MRI can allow a physician to evaluate parts of the body non invasively that may not be assessed adequately by other imaging methods, like ultrasound. MRI does not use harmful ionizing radiation like x-ray scan or carry any known long-term health risks.
What is LiverMultiScan?
LiverMultiScan is a non-invasive method that accurately assesses signs of liver disease. It is a software that uses MRI scans to provide quantitive metrics of liver health in an easy-to-understand report, empowering your physician with information to aid diagnosis and enhance the management of your liver disease.
LiverMultiScan is provided as a service by Perspectum.
LiverMultiScan is provided as a service by Perspectum.
What does LiverMultiScan measure?
LiverMultiScan provides your physician with three quantitative metrics of liver health- corrected T1 or cT1, PDFF, and LIC – in a single scan indicating the extent of disease activity, fat content, and iron concentration in your liver, respectively.
LiverMultiScan is the only technology measuring cT1, which can assess liver disease activity and predict the likely future course of the disease.
LiverMultiScan is the only technology measuring cT1, which can assess liver disease activity and predict the likely future course of the disease.
What should I expect during an MRI?
On arrival at a Perspectum-approved imaging centre, you would either be asked to change into a gown or allowed to wear metal-free loose clothing depending on the imaging center's rules. Next, you will be asked to lie on your back on a flat-bed, and a trained MRI technician will slide it into the MRI machine until your body is in the correct position.
You will be asked to lie still, breathe in and out, and hold your breath for a few sections while your liver is scanned. During this time, the scanner will make loud tapping noises as the scanner coils are turned on and off. You will be given earplugs or headphones to reduce the noise.
After you scan, the MRI data will be transferred to Perspectum, where specialized data analysts will produce a LiverMultiScan report with quantitative metrics of liver health for interpretation by a physician
You will be asked to lie still, breathe in and out, and hold your breath for a few sections while your liver is scanned. During this time, the scanner will make loud tapping noises as the scanner coils are turned on and off. You will be given earplugs or headphones to reduce the noise.
After you scan, the MRI data will be transferred to Perspectum, where specialized data analysts will produce a LiverMultiScan report with quantitative metrics of liver health for interpretation by a physician
How long does a LiverMultiScan take?
Typically scanning time is around 5 minutes. Most patients are in the scanner room for less than 15 minutes.
Are there any risks associated with a LiverMultiScan?
As the MRI acquisition for LiverMultiScan is non-invasive, it does not carry any known long-term health risks. Patients with metal implants, pacemakers or artificial heart valves should inform the technologist, as in some cases, it may not be safe to undergo the examination.
Patients who are or might be pregnant should seek advice from their physician and/or inform the MRI technician before the scan.
Patients who are or might be pregnant should seek advice from their physician and/or inform the MRI technician before the scan.
Is a LiverMultiScan painful?
No. The MRI scan is completely non-invasive and does not require any injections. Most patients don’t experience any discomfort during the procedure. Patients prone to claustrophobia (a fear of tight spaces) may experience some discomfort, which is usually very manageable, as the time needed for the scan is very short.
What happens after a LiverMultiScan?
After undergoing an MRI scan at a Perspectum-approved imaging center, your MRI data will be transferred to Perspectum through our secure data transfer facility. The captured images will be analyzed using LiverMultiScan at Perspectum’s dedicated image analysis center.
Subsequently, a LiverMultiScan report containing the quantitative metrics and images indicating the status of your liver health, will be returned to the imaging center for interpretation by a physician.
The information provided, as well as other diagnostic tests or procedures, will be used by your physician to assess the health of your liver in the context of your disease.
Subsequently, a LiverMultiScan report containing the quantitative metrics and images indicating the status of your liver health, will be returned to the imaging center for interpretation by a physician.
The information provided, as well as other diagnostic tests or procedures, will be used by your physician to assess the health of your liver in the context of your disease.
How can I get a LiverMultiScan?
Ask your physician or an imaging facility offering LiverMultiScan.
How does my physician use the metrics to diagnose liver disease?
At their discretion, your physician will use the analyzed results provided in the LiverMultiScan report with other diagnostic test results (e.g., blood tests, ultrasound scans, etc.) to diagnose your liver disease. Very high fat and/or iron in your liver can impact the accuracy of LiverMultiScan’s results – this information will be shared with your physician.
Can a patient use a LiverMultiScan to diagnose liver disease?
Patients themselves should never interpret LiverMultiScan reports. The metrics provided by LiverMultiScan are exclusively intended for interpretation by trained physicians as additional supporting information for the diagnosis of liver disease.
LiverMultiScan is a support tool for diagnosis, and responsibility for diagnosis and treatment decisions remains the sole responsibility of the interpreting physician.
LiverMultiScan is a support tool for diagnosis, and responsibility for diagnosis and treatment decisions remains the sole responsibility of the interpreting physician.
Is LiverMultiScan a medical device?
Yes. LiverMultiScan is a Magnetic Resonance Diagnostic Device regulated under Section 21 CFR 892.1000 of the United States Code of Federal Regulations. It is a Class II device with product code LNH (Magnetic Resonance Imaging System).
It is cleared for commercial use in the United States under Premarket Notification 510(k) number K213960.
It is cleared for commercial use in the United States under Premarket Notification 510(k) number K213960.
How secure is the service?
Perspectum has designed its products and services to comply with privacy laws, including GDPR, UK GDPR, and HIPAA.
Perspectum’s data security infrastructure is supported by an ISO 27001 and ISO 13485 compliant quality management system designed around a defence-in-depth approach with multiple layers of redundancy, surveillance, physical access controls, and audit logs. Access to the Perspectum Portal is controlled and secured by SSL encryption mandating a HTTPS protocol for web-based data transmissions to prevent eavesdropping, tampering, and forgery. All data is encrypted while in storage in Perspectum Portal and routinely backed-up to an alternative secondary physical location to ensure service continuity.
Perspectum Portal is hosted by Amazon Web Services (AWS), a market-leading provider of cloud platform solutions that employs rigorous and sophisticated security processes to guard data privacy from malicious or accidental incident.
Perspectum’s data security infrastructure is supported by an ISO 27001 and ISO 13485 compliant quality management system designed around a defence-in-depth approach with multiple layers of redundancy, surveillance, physical access controls, and audit logs. Access to the Perspectum Portal is controlled and secured by SSL encryption mandating a HTTPS protocol for web-based data transmissions to prevent eavesdropping, tampering, and forgery. All data is encrypted while in storage in Perspectum Portal and routinely backed-up to an alternative secondary physical location to ensure service continuity.
Perspectum Portal is hosted by Amazon Web Services (AWS), a market-leading provider of cloud platform solutions that employs rigorous and sophisticated security processes to guard data privacy from malicious or accidental incident.
Healthcare Professionals
How can I as a physician use LiverMultiScan to aid in making a diagnosis?
LiverMultiScan provides measurements derived from MR data which can be used for tissue quantification and may be used as part of a wider diagnostic process. When interpreted by a trained physician, these images and the physical parameters derived from the images yield information that may assist in the diagnosis of liver disease.
Inflammation and fibrosis are increasingly believed to be part of a continuum of disease progression. Injury to the liver parenchyma, such as deposition of liver fat resulting from a poor diet, hereditary or acquired iron overload, or viral infection, can all lead to an inflammatory response. If the injury persists, collagen, the major component of scar tissue, is deposited in the liver. In advanced stages of fibrosis, the collagen fibers cross-link (known as bridging fibrosis), eventually resulting in the nodular phenotype that is the hallmark of cirrhosis.
Inflammation and fibrosis are increasingly believed to be part of a continuum of disease progression. Injury to the liver parenchyma, such as deposition of liver fat resulting from a poor diet, hereditary or acquired iron overload, or viral infection, can all lead to an inflammatory response. If the injury persists, collagen, the major component of scar tissue, is deposited in the liver. In advanced stages of fibrosis, the collagen fibers cross-link (known as bridging fibrosis), eventually resulting in the nodular phenotype that is the hallmark of cirrhosis.
How do I know LiverMultiScan can be used on my patient?
LiverMultiScan has no demographic or population restrictions. LiverMultiScan analyses liver tissue characteristics from appropriately acquired MR datasets, the metrics themselves that can be produced from the tissue characteristics are not deemed to differ between demographics/populations.
Before my patient has a LiverMultiScan, what preparation is needed?
Patients should be nil-by-mouth (no food or drink) for four hours before a scan. However, a patient can have food or drink if required to take medication during this period.
Patients do not need to abstain from alcohol in the days prior to the scan.
Patients do not need to abstain from alcohol in the days prior to the scan.
Is LiverMultiScan done with a contrast agent?
No. LiverMultiScan images must always be acquired BEFORE administering a contrast agent. If a contrast agent has been administered prior to undergoing a LiverMultiScan, no quantification can be made.
Is LiverMultiScan covered in any clinical guidelines?
Yes. As of 03/13/2022, Carelon (former AIM Specialty Health) Clinical Guidelines deem LiverMultiScan medically appropriate for managing chronic liver disease.
Additionally, LiverMultiScan is recognized in clinical guidelines by American Association for the Study of Liver Diseases (AASLD) American Association of Clinical Endocrinology (AACE) and American Gastroenterological Association (AGA), for assessment in NAFLD.
Additionally, LiverMultiScan is recognized in clinical guidelines by American Association for the Study of Liver Diseases (AASLD) American Association of Clinical Endocrinology (AACE) and American Gastroenterological Association (AGA), for assessment in NAFLD.
How do I order an LMS? What are the CPT codes and when/how can they be used?
LiverMultiScan can be ordered through your EMR system or via an order. If submitting an order, send your order to the selected imaging center/hospital with the applicable diagnosis. If you are not working directly with the payor on obtaining the prior authorization, please include clinical notes and prior testing.
LiverMultiScan has two applicable CPT codes, 0648T and 0649T. CPT code 0648T is used when a LiverMultiScan only is performed or in addition to an MRE. For CPT code 0649T, this code is used when LiverMultiScan is being performed in addition to another diagnostic MRI scan (i.e. MRI Abdomen).
LiverMultiScan has two applicable CPT codes, 0648T and 0649T. CPT code 0648T is used when a LiverMultiScan only is performed or in addition to an MRE. For CPT code 0649T, this code is used when LiverMultiScan is being performed in addition to another diagnostic MRI scan (i.e. MRI Abdomen).
Why I haven’t got a report?
Certain image artefacts and acquisition errors may yield unreliable measurements of the liver and due to this, although it is seldom, it may not be possible to generate a report. If this is the case you will receive an email notification.
An example of this is patient motion during image acquisition; whilst the patient acquisition manual stresses the importance of controlled breathing to minimize the likelihood of motion, breathing and moving to get comfortable may occur.
An example of this is patient motion during image acquisition; whilst the patient acquisition manual stresses the importance of controlled breathing to minimize the likelihood of motion, breathing and moving to get comfortable may occur.
What are reference physiological ranges for T2*, cT1 and PDFF?
The reference ranges presented below should be used as a guideline for expected values in a ‘healthy’ population when interpreting the LiverMultiScan report.
