Dallas, Texas, July 7, 2020 – Perspectum is collaborating with top medical institutions to evaluate the diagnostic performance of their flagship product, LiverMultiScan®, at identifying eligible patients with non-alcoholic steatohepatitis (NASH) for enrollment into clinical trials. LiverMultiScan is a non-invasive MR imaging solution for quantitative characterization of liver tissue that could help sponsors both accelerate and improve their success rate in enrollment, something which has proven to be notoriously challenging in NASH studies.
NASH is a progressive form of fatty liver disease and is estimated to affect between 5-12% of the US adult population. Identification and enrollment of patients in clinical trials for NASH typically requires assessment of clinical risk factors prior to a confirmatory liver biopsy. However, these risk factors are often not specific or sensitive enough to discriminate early, non-fibrotic NASH from more advanced stages of fibro-inflammation, leading to high levels of screen fails on biopsy as well as increased cost and risks from an invasive procedure.
"The development and validation of novel, non-invasive biomarkers for NASH is an exciting and important area of research that is expected to transform how we diagnose and evaluate patients with suspected NASH in both clinical practice and clinical trials." Dr. Arun Sanyal MD, Principal investigator.
Donna Cryer, founder of the Global Liver Institute said of the study; "This multi-site trial will provide important data demonstrating the value of LiverMultiScan, a non-invasive solution that will help create better outcomes for patients living with liver disorders and abnormalities. As the prevalence of NASH continues to grow, the need for a fast, precise, and non-invasive diagnostic tool that can accurately quantify and monitor disease activity in NASH patients is becoming increasingly important".
The trial, Non-Invasive Quantification of Liver Health in NASH (N-QUAN), is sponsored by Perspectum and conducted in collaboration with Virginia Commonwealth University, University of Virginia, Mount Sinai, and Liver Centers of Texas. 225 patients with suspected NASH will be recruited as part of this prospective study over a 12-month period. N-QUAN is registered on ct.gov under NCT04054310.
