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%)