Ironically, the 2018 NASH-TAG conference in the Rocky Mountains featured much less snow than we have “enjoyed” in the northeast this winter. Weather forced one speaker to present remotely from his home—thank goodness web conferencing technology can now mitigate travel cancellations! In 2018, various speakers presented some very promising results including compounds from Gilead (GS-0976), Bristol Myers Squibb (BMS-986036), NGM Bio (NGM282), Galectin (GR-MD-02), Madrigral (MGL-3196), Cirius Therapeutics (MSDC-0602), DeuteRx (DRX-065), Inventiva Pharma (Lanifibranor), 3-V Biosciences (TVB-2640), Novartis (LIK066), Bird Rock Bio (Namacizumab), and others.
One of the main takeaways from the 2018 conference was that noninvasive techniques such as imaging are beginning to replace invasive biopsies, long considered the gold standard, to measure liver fat, fibrosis, inflammation and cellular damage. Most of the presented studies leveraged MRI-PDFF to measure fat in the liver, some studies used FibroScan to measure liver stiffness and quantify liver fat using the controlled attenuation parameter (CAP), and many studies used magnetic resonance elastography (MRE) to measure liver stiffness. A few studies even used Liver MultiScan™, which demonstrated moderate correlation between corrected T1 relaxation time (cT1) and several biopsy measurements. Dr. Ehman, from the Mayo Clinic closed out the conference by presenting some new research using 3D MRE. Dr. Ehman demonstrated some exciting new results; with machine learning, MRI-PDFF and 3D MRE scans classified NASH patients nearly as well as a biopsy.
Going forward, the liver industry faces a challenge with availability of advanced imaging. As new technologies are developed in academia, the number of clinical scanners that can implement new sequences are limited. Over time, availability of advanced scanner capabilities will increase to the point where new technology can be used in a small to medium sized trial. The hope is that eventually, new technology will become universal and allow much larger clinical trials. Based on current population data and MRI scanner density data, there are currently about 22,000 MRI scanners in North America and Europe with an estimated 36,000 MRI scanners worldwide. MRI-PDFF can be implemented on the majority of scanners now, so its availability is not of great concern. MRE requires the purchase of additional hardware and software and is currently available on about 1,000 scanners worldwide corresponding to less than 3% of global scanners. 3D MRE is currently only available on GE scanners, so the advanced measurements 3D MRE provides are only available on less than 2% of global scanners. This availability challenge is not limited to MRE, but persists with other new technologies such as Liver MultiScan™ from Perspectum Diagnostics, which requires an advanced cardiac sequence.
The good news is that the number of sites that can implement these technologies is increasing. To identify locations of currently installed MRE-capable scanners, Resoundant has developed a tool called MRE:connect. Even though less than 3% of scanners worldwide are MRE-capable, there is likely an MRE-capable scanner in any given city in the US, as well as many cities in Europe and many larger cities throughout the world. Given the limited availability of scanners capable of advanced liver imaging, enlist the help of your central imaging vendor early in the site selection process to avoid the frustration of a clinical site that cannot support advanced liver imaging for a given trial.
Download our complimentary webinar, Body Composition in Clinical Trials – From BMI to MRI, to learn alternative, noninvasive imaging methods to determine body composition for your NASH clinical trial.