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HepaFat for Patients

Frequently Asked Questions

Please click on the question(s) below to expand the answer for each. If your question is not listed below, please contact us directly at info@resonancehealth.com for further information.

Magnetic Resonance Imaging (MRI) is a very safe 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.​
Nonalcoholic Fatty Liver Disease (NAFLD) is a type of fatty liver disease that is not related to heavy alcohol use. There are two kinds of NAFLD, including:

  • Simple fatty liver, also called non-alcoholic fatty liver (NAFL), is a form of NAFLD in which you have fat in your liver but little or no inflammation or liver cell damage. Simple fatty liver typically does not progress to cause liver damage or complications;
  • Non-alcoholic steatohepatitis (NASH), occurs when inflammation is present in the liver with evidence of liver cell damage, as well as fat. Inflammation and liver cell damage can trigger fibrosis, or scarring of the liver. NASH may also lead to cirrhosis or liver cancer.
Cirrhosis is a type of severe and usually irreversible liver disease caused by long-term liver damage. Healthy liver tissue is increasingly replaced by scar tissue in a process called fibrosis. The scar tissue damages the normal structure of the liver, which affects the flow of blood through the liver. Without correct blood flow, the liver can’t function normally. Cirrhosis increases the risk of developing liver cancer.
HepaFat-Scan is a safe, painless and non-invasive MRI-based solution for measuring the volume fraction of fat in liver tissue. HepaFat-Scan is provided as an image analysis service; with analysis and reporting provided from the Resonance Health ISO 13485 certified Service Centre via our Quality Assured Service Delivery model.

The HepaFat-Scan software is the first and only method with regulatory clearances (USA – FDA, Europe – CE Mark, Australia – TGA) for quantitative measurement of liver fat that has been clinically validated against independent measurements of the volume fraction of fat in liver biopsy specimens in a clinical study.

HepaFat-Scan reports volumetric fraction of fat in the liver, a measure that can be directly compared to a volumetric biopsy fat fraction measurement.

HepaFat-Scan is now available for routine clinical use and for use in pharmaceutical company clinical trials.
HepaFat-Scan has been developed by Resonance Health to provide a non-invasive quantitative measurement of the triglyceride fat fraction in a defined region of the liver. The fat fraction is expressed as a percentage and represents the volume fraction of vesicular fat within the liver region; the volumetric liver fat fraction or VLFF. A fat fraction result of 10% would indicate that 10% of the volume within the liver region is composed of fat.

When interpreted by a trained physician, the results provide information that can aid in diagnosis.

HepaFat-Scan 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)
  • Patient information can be seen on the first page at the top of the report.
  • On the front page, the mean volume fraction of fat in the liver is displayed in the square box below the patient information. In this report, the 21.8% percentage indicates the mean volume fraction of fat in the liver of the patient.

HepaFat-AI is a fully automated analysis service that uses Artificial Intelligence (AI) combined with a non-invasive MRI-based technique to automatically analyse MRI datasets to generate an estimate of the patient’s volumetric liver fat fraction (VLFF).

Resonance Health has applied to the US FDA for clearance for HepFat-AI, and Resonance Health is working towards applying for regulatory clearance for HepaFat-AI from the TGA and CE Mark.  HepaFat-AI is currently available only for use in an investigational context (not cleared by FDA, TGA, and does not have CE mark).

No. HepaFat-Scan and HepaFat-AI use images acquired using magnetic resonance imaging (MRI). MRI works using electro-magnetic energy, not ionizing radiation. 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 technologists beforehand.

HepaFat-Scan and HepaFat-AI use MRI images that are acquired using single breath hold techniques. Results are then analysed and returned instantly back to the clinician (HepaFat-AI) or to the MRI Centre within a target time of two business days (HepaFat-Scan).

No medication is required before this test.
Being non-invasive, HepaFat-Scan and HepaFat-AI are painless tests. Some people may experience anxiety in an MRI scanner as it can be noisy and can feel a little claustrophobic, however MRI technologists are very experienced at putting patients at ease.

Sites that are verified (set up) for HepaFat-Scan or HepaFat-AI should be able to assist you with information on pricing for these services.

Resonance Health is an Australian healthcare company specializing in the development and commercialization of magnetic resonance imaging (MRI) related technologies and services. Resonance has extensive experience and expertise in providing objective, reproducible, and quantitative imaging measurements and core laboratory services. Our Gold Standard MRI technology (FerriScan) for liver iron concentration measurement alongside our Cardiac T2* MRI service has become established in many international ‘Standards of Care’ for Thalassemia and we have well over a decade of expertise in this clinical indication. We provide meticulous, standardized and quality assured methodology to a comprehensive range of imaging core lab services.
You’re welcome to explore this HepaFat page in greater detail. Alternatively you may visit our corporate website at www.resonancehealth.com or email us directly at info@resonancehealth.com for additional information.

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