Institute Director Helps Evaluate AI Tool to Assess Liver Tissue
By A.J. Hostetler
Scientists have developed a groundbreaking tool that can utilize artificial intelligence to improve clinical trials for liver diseases.
The tool, AIM-MASH, can help assess the liver of a patient with the disease called MASH, or metabolic dysfunction-associated steatohepatitis. Clinical trials for MASH require the examination of liver tissue samples to determine trial eligibility and assess treatment effectiveness. However, inconsistencies in doctors' interpretations of these samples often lead to challenges in the trials.
In a paper published by the journal Nature Medicine, VCU Stravitz-Sanyal Institute for Liver Disease and Metabolic Health Director Arun Sanyal, M.D., and colleagues describe how AIM-MASH could address this issue by offering consistent, accurate assessments of liver tissue samples. AIM-MASH is a suite of algorithms that seeks to predict the location, extent and severity of histologic biomarkers of MASH. Tests show that its predictions align with those of experts, establishing it as a reliable tool, the study authors wrote.
AIM-MASH has potential to enhance the accuracy and efficiency of clinical trials by reducing disagreements among doctors examining liver tissue and providing clear measurements of patient responses to treatments, the researchers said. This improvement could accelerate the discovery of effective treatments for MASH, making the process quicker and more reliable.
MASH is a severe liver condition characterized by liver inflammation and damage. It can progress to cirrhosis, liver cancer, and even liver failure. Its prevalence is increasing, particularly among women and older adults in the United States, and it is a leading cause of liver transplants.
Understanding and treating MASH is critical for public health due to its growing prevalence and significant health impacts. The disease not only affects individuals’ health and quality of life but also imposes a substantial economic burden through health care costs and lost productivity.
The development of AIM-MASH is important because it may improve the accuracy and consistency of clinical trials that evaluate new treatments for MASH. Currently, given that the manual evaluation of liver tissue samples by doctors can vary significantly, this can affect trial outcomes and the development of new therapies.
Standardizing the assessment of liver tissue samples to ensure consistency would make clinical trials more reliable, helping to identify potential treatments more rapidly and accurately. For patients with MASH, this could mean a better chance of receiving effective treatments sooner, improving their health and quality of life.
Validation studies required to support AIM-MASH application in clinical trials are underway. The FDA is evaluating the AI tool, which was developed by PathAI, a Boston-based biotech company dedicated to advancing AI and digital pathology solutions.
“This tool is well poised to improve the accuracy and reproducibility of pathologists’ evaluation of liver biopsies within scalable workflows that can accommodate the increasing demand for MASH clinical trials,” the paper’s authors wrote. “With the urgent unmet need of patients with MASH, we hope that AIM-MASH can aid pathologists in the clinical trial setting.”