Renal protection CT protocol using low-dose and low-concentration iodine contrast medium in at-risk patients of HCC and with chronic kidney disease: a randomized controlled non-inferiority trial

Abstract

Background Although efforts have been made to reduce the dose of Contrast Medium (CM) to improve patient safety, there are ongoing concerns regarding its potential effects on image quality and diagnostic performance. Moreover, research is lacking to establish a lower limit for safe and effective CM dose reduction. To determine whether the image quality of contrast-enhanced liver computed tomography (CT) using a reduced amount of iodinated CM was similar to that of standard liver CT. Methods We enrolled participants at risk for hepatocellular carcinoma with decreased estimated glomerular filtration rates (< 60 mL/min/1.73m2). Participants were randomly assigned to the standard group or the renal protection protocol (RPP) group. In the standard group, images were reconstructed using hybrid iterative reconstruction (iDose), while in the RPP group, low monoenergetic (50-keV) images and deep learning (DL)-based iodine-boosting reconstruction were used. Four radiologists independently assessed image quality and lesion conspicuity. Results Fifty-two participants were assigned to the standard (n = 25) or RPP (n = 27) groups. The iodine load was significantly lower in the RPP group than in the standard group (301.5 ± 1.71 vs. 524 ± 7.37 mgI/kg, P < 0.001). The 50-keV and DL-based iodine-boosting images from the RPP group exhibited higher image contrast than those from the standard group during arterial (3.60 ± 0.65, 3.75 ± 0.60, and 3.09 ± 0.43, respectively) and portal venous phases (4.01 ± 0.49, 3.86 ± 0.42, and 3.21 ± 0.31, respectively) (P < 0.05 for all). Overall image quality was superior in the RPP group (P < 0.05 for all). No significant difference in lesion conspicuity was observed (P > 0.017). Conclusions The reduction in image contrast and overall image quality caused by decreased CM can be restored using either low monoenergetic imaging or DL-based iodine-boosting reconstruction. Trial registration clinicaltrials.gov, NCT04024514, Registered July 18, 2019, prospectively registered, https://classic.clinicaltrials.gov/ct2/show/NCT04024514.