Precision – Focus on whole liver

Antaros Medical and its staff have been performing liver fat quantification in interventional studies for over 15 years, starting with Magnetic Resonance Spectroscopy (MRS) based techniques and later magnetic resonance imaging proton density fat fraction (MRI-PDFF).

 

Whole liver assessment of liver MRI-PDFF and liver volume

 

The Antaros Medical method for MRI-PDFF has always included assessment of the entire liver from a 3D MRI scan, avoiding bile ducts and veins in the image analysis. This is done to use as much data as possible from each scan to reduce variability and hence reducing the number of subjects required for clinical studies. Whenever possible, we include a morphological liver volume measurement which allows assessment of unforeseen changes in liver physiology. An example of this is the increase in liver volume seen by treatment using Fenofibrate (Oscarsson J et al, J Clin Lipidol. 2018). The approach to assess total liver fat volume increases the sensitivity to detect changes in small studies with short duration, enabling the use of liver PDFF in early phase studies (even in Ph1b) to detect dose response

 

Our MRI-PDFF method has been implemented by us in over 25 clinical studies in non-alcoholic fatty liver disease (NAFLD) patients including large, global, multi-centre, multi-vendor trials with over 50 sites. All images are centrally read at our CoreLab by certified analysts. An example below are images from a recent publication (Johansson L et al, Diabetes, Obesity, Metabolism 2020) where the MRI-PDFF images from this 52-week trial were displayed on the journal cover.

“Our approach to liver fat quantification increases the sensitivity to detect changes in small studies with short duration and can therefore be used in early phase studies, even Phase 1b, to detect dose response”

 

Lars Johansson

Chief Scientific Officer