Point-of-care magnetic resonance technology to measure liver fat: Phantom and first-in-human pilot study.

Abstract

To assess feasibility and accuracy of point-of-care (POC) NMR-proton density fat fraction (PDFF) in phantoms and in a human pilot study in a POC setting. POC NMR (LiverScope, Livivos, San Diego CA) PDFF measurements were obtained of certified phantoms with known PDFF values (0%-40%). In an institutional review board-approved, Health Insurance Portability and Accountability Act-compliant prospective human study, a convenience sample of participants from an obesity clinic was enrolled (November 2020 to June 2021). The inclusion criteria required body mass index (BMI)=27-40 kg/m2 and willingness to undergo POC NMR and MRI-PDFF measurements. Liver PDFF was measured by POC NMR and, within 35 days after, by a confounder corrected CSE MRI PDFF acquisition and reconstruction method. The adverse events were documented and linear regression analyses were performed. POC NMR-PDFF measurements agreed with known phantom PDFF values (R2 =0.99). Fourteen participants were enrolled in the pilot human study. MRI-PDFF could not be obtained in 4 participants (claustrophobia reaction, n=3, exceeded size of MR scanner bore, n=1). POC NMR was unevaluable in 2 participants (insufficient signal penetration depth, n=1, failure to comply with instructions, n=1). Technical success was 11 of 13 (85%) for POC NMR PDFF. In 7 participants (4 female; 31-74 years old; median BMI 35 kg/m2 ), MRI-PDFF (range, 2.8%-18.1%), and POC NMR-PDFF (range, 3%-25.2%), agreed with R2 =0.94. POC NMR had no adverse events. POC NMR measures PDFF accurately in phantoms and, in a first-in-human pilot study, is feasible and accurate in adults with obesity. Further testing to determine precision and accuracy across larger and more diverse cohorts is needed.