Trial results for an ultrasound-based liver fat quantification pilot study in MASH (NASH) were posted on ClinicalTrials.gov on 2026-01-23, involving 60 participants. The study found that ultrasound biomarkers, particularly acoustic attenuation, correlated with MRI Proton Density Fat Fraction (MRI-PDFF) measurements, with a Pearson correlation coefficient of 0.7331 for acoustic attenuation.
Background
Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), is a severe form of non-alcoholic fatty liver disease (NAFLD) characterized by liver inflammation and damage, which can progress to fibrosis, cirrhosis, and liver cancer. Accurate and non-invasive methods for quantifying liver fat are crucial for diagnosing MASH/NAFLD, monitoring disease progression, and assessing treatment efficacy. Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is considered a highly accurate method for liver fat quantification. However, its accessibility and cost can be limiting. Investigating alternative, more accessible imaging techniques like ultrasound for liver fat quantification could significantly improve patient management.
Trial design
This completed pilot study, designated as Phase NA, enrolled 60 participants diagnosed with or at risk for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The primary objective was to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat. This was achieved by comparing specific ultrasound-derived biomarkers with liver fat percentage obtained from MRI-PDFF measurements. All subjects underwent a series of medical imaging procedures using both ultrasound and MRI modalities.
Key results
The study reported several key measurements and analyses regarding the correlation of ultrasound biomarkers with MRI-PDFF and the feasibility of the ultrasound technique:
- For the Hepatorenal Index (HRI) ultrasound biomarker, the mean value was 1.6 (Standard Deviation 0.7 Hepatorenal Index).
- For the Acoustic Attenuation ultrasound biomarker, the mean value was 1.0 (Standard Deviation 0.7 dB/cm/MHZ).
- For the Tissue Stiffness ultrasound biomarker, the mean value was 5.9 (Standard Deviation 1.8 kPa).
- The same-day inter-operator variability for HRI was a mean of -0.1 (Standard Deviation 0.4 Hepatorenal Index).
- The same-day inter-operator variability for Acoustic Attenuation was a mean of 0.0 (Standard Deviation 0.1 dB/cm/MHZ).
- The same-day inter-operator variability for Tissue Stiffness was a mean of 0.1 (Standard Deviation 1.9 Tissue stiffness (kPa)).
- The data acquisition failure rate for HRI was 1 participant.
- The data acquisition failure rate for Acoustic Attenuation was 0 participants.
- The data acquisition failure rate for Tissue Stiffness was 1 participant.
Key analyses showed correlations between ultrasound biomarkers and MRI-PDFF:
- The Pearson correlation coefficient between quantitative ultrasound biomarker "Hepatorenal Index (HRI)" and MRI-PDFF was reported as 0.5749, 0.6143, and 0.5944 (estimated from a mixed model).
- The Pearson correlation coefficient between quantitative ultrasound biomarker "Acoustic attenuation" and MRI-PDFF was reported as 0.6824, 0.7331, and 0.7066 (estimated from a mixed model).
What this means
The results from this pilot study suggest that investigational ultrasound techniques show promise for quantifying liver fat in individuals with MASH (NASH) and NAFLD. The observed correlations between ultrasound biomarkers, particularly acoustic attenuation, and MRI-PDFF indicate that ultrasound could serve as a valuable, non-invasive tool for assessing liver steatosis. The reported inter-operator variability and low data acquisition failure rates for most biomarkers also suggest the practical feasibility of these ultrasound measurements in a clinical setting. This could potentially offer a more accessible and cost-effective alternative or complement to MRI-PDFF for diagnosis and monitoring of liver fat, which is critical for managing MASH/NAFLD progression.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04657523, titled "Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study", were posted on 2026-01-23 on clinicaltrials.gov.