The aim of this study was to intraindividually compare the conspicuity of focal liver lesions (FLLs) between low- and ultra-low-dose computed tomography (CT) with deep learning reconstruction (DLR) and standard-dose CT with model-based iterative reconstruction (MBIR) from a single CT using dual-split scan in patients with suspected liver metastasis via a noninferiority design. This prospective study enrolled participants who met the eligibility criteria at 2 tertiary hospitals in South Korea from June 2022 to January 2023. The criteria included (a) being aged between 20 and 85 years and (b) having suspected or known liver metastases. Dual-source CT scans were conducted, with the standard radiation dose divided in a 2:1 ratio between tubes A and B (67% and 33%, respectively). The voltage settings of 100/120 kVp were selected based on the participant's body mass index (<30 vs ≥30 kg/m2). For image reconstruction, MBIR was utilized for standard-dose (100%) images, whereas DLR was employed for both low-dose (67%) and ultra-low-dose (33%) images. Three radiologists independently evaluated FLL conspicuity, the probability of metastasis, and subjective image quality using a 5-point Likert scale, in addition to quantitative signal-to-noise and contrast-to-noise ratios. The noninferiority margins were set at -0.5 for conspicuity and -0.1 for detection. One hundred thirty-three participants (male = 58, mean body mass index = 23.0 ± 3.4 kg/m2) were included in the analysis. The low- and ultra-low- dose had a lower radiation dose than the standard-dose (median CT dose index volume: 3.75, 1.87 vs 5.62 mGy, respectively, in the arterial phase; 3.89, 1.95 vs 5.84 in the portal venous phase, P < 0.001 for all). Median FLL conspicuity was lower in the low- and ultra-low-dose scans compared with the standard-dose (3.0 [interquartile range, IQR: 2.0, 4.0], 3.0 [IQR: 1.0, 4.0] vs 3.0 [IQR: 2.0, 4.0] in the arterial phase; 4.0 [IQR: 1.0, 5.0], 3.0 [IQR: 1.0, 4.0] vs 4.0 [IQR: 2.0, 5.0] in the portal venous phases), yet within the noninferiority margin (P < 0.001 for all). FLL detection was also lower but remained within the margin (lesion detection rate: 0.772 [95% confidence interval, CI: 0.727, 0.812], 0.754 [0.708, 0.795], respectively) compared with the standard-dose (0.810 [95% CI: 0.770, 0.844]). Sensitivity for liver metastasis differed between the standard- (80.6% [95% CI: 76.0, 84.5]), low-, and ultra-low-doses (75.7% [95% CI: 70.2, 80.5], 73.7 [95% CI: 68.3, 78.5], respectively, P < 0.001 for both), whereas specificity was similar (P > 0.05). Low- and ultra-low-dose CT with DLR showed noninferior FLL conspicuity and detection compared with standard-dose CT with MBIR. Caution is needed due to a potential decrease in sensitivity for metastasis (clinicaltrials.gov/ NCT05324046).
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