Radiology considerations for the PREMIUM study: a multicenter randomized controlled trial of abbreviated MRI versus ultrasound for liver cancer screening in cirrhosis.
This paper describes the rationale and radiology considerations in the implementation of the Preventing Liver Cancer Mortality through Imaging with Ultrasound versus MRI (PREMIUM) study. PREMIUM is a multicenter, randomized controlled trial sponsored by the Department of Veterans Affairs comparing dynamic contrast-enhanced (DCE) abbreviated MRI (aMRI) plus serum AFP versus ultrasound (US) plus serum AFP for hepatocellular carcinoma (HCC) screening in patients with cirrhosis. PREMIUM aims to randomize 4,700 participants across over 47 Veterans Affairs Medical Centers to semiannual surveillance for up to eight years, with HCC-related mortality as the primary endpoint. To date, 35 sites have been activated with 1,085 patients randomized. To ensure uniform implementation and reporting of per-protocol screening, the PREMIUM Radiology Workgroup developed standardized imaging protocols, structured LI-RADS-based reporting templates, and a centralized training program for radiologists and technologists. They also perform ongoing quality control on both scans and reports. The aMRI protocols utilize multiphasic post-contrast imaging to allow LI-RADS scoring. A non-contrast-enhanced aMRI protocol is available for participants who develop renal impairment or contrast allergy during the study. US protocols conform to US LI-RADS standards. Structured reporting promotes consistency in documentation of findings, visualization scores, and follow-up recommendations. A centralized Image Repository was established, incorporating advanced de-identification methods to remove metadata and pixel-embedded protected health information from imaging files. More than 20,000 curated liver MRI and US exams are anticipated, supporting both trial outcomes and future radiomics and artificial intelligence research. PREMIUM aims to determine whether screening for HCC with a DCE aMRI protocol reduces HCC-related mortality and also facilitates ancillary studies utilizing the Image Repository.
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