Calimetrix Phantoms in NAFLD/NASH Clinical Trials

NASH Clinical Trials with a PDFF endpoint use Calimetrix Fat-Fraction Phantoms for site qualification and quality assurance. Calimetrix housing-based spherical PDFF phantoms and PDFF Phantom Packs can be used synergistically in the same trial, as described below:

PDFF Phantom Packs in clinical trials

  • Provide additional assurance on a per-patient basis

  • Set of 5 vials with different PDFF values (0%, 10%, 20%, 30%, and 40% PDFF)

  • Phantom Packs can be scanned within the field of view (FOV) of each patient MRI scan, providing a direct reference for PDFF quantification, reliably embedded in each patient scan

  • Positioning pad accessories available for easy, comfortable, and repeatable placement of the vials within patient field of view. Click here to learn more.

Spherical PDFF phantoms in clinical trials

  • Form the foundation of robust PDFF Site Qualification & Quality Assurance

  • Designed to provide excellent image quality with maximum robustness to changes in scan set-up and imaging parameter selection, including changes due to user error

  • Fully sample the clinically relevant PDFF range (0%, 2.5%, 5%, 7.5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 100% PDFF), including higher granularity sampling of the lower PDFF range (clinically-relevant PDFF threshold for non-alcoholic fatty liver disease (NAFLD) is between ~3-6%)