NASH Trial With MRI-PDFF and Liver Stiffness

Challenge

Quantitative liver imaging biomarkers are only as reliable as the scanners that produce them. In this NASH program, vendor differences in MRI-PDFF and MR elastography implementation threatened the comparability of liver fat fraction and stiffness measurements across 50 sites. Because these quantitative endpoints would inform Phase IIb dose selection, even modest cross-vendor bias carried direct consequences for one of the trial's most consequential decisions.

Our Solution

Intrinsic Imaging implemented phantom-based scanner qualification to characterize and calibrate each platform before enrollment, then verified sequence parameters on every submission at the point of receipt. Central quantitative review of liver fat fraction and stiffness was performed under uniform analysis protocols, with vendor-specific considerations documented and controlled. The result was a harmonized quantitative dataset in which measurements could be compared meaningfully across sites, scanners, and timepoints.

Results

• Evaluable scan rate above 96%
• Consistent PDFF values across vendors
• Reliable data for the Phase IIb dose selection