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Abstract Purpose This prospective pilot study was performed to evaluate non-inferiority between CEUS and the clinical gold standard of CECT/MRI in patients with HCC following TACE in a United States population using Lumason® contrast agent and Liver Reporting and Data System (LIRADS). Methods Following institutional review board protocols, adult patients with a first-time diagnosis of HCC were identified and consented for inclusion. Follow-up CT/MRI was directed by referring clinicians and CEUS was performed on the same day. CEUS evaluated for treated lesion(s), any new lesion(s), and portal vein thrombus before and after Lumason®. Any subsequent follow-up imaging was reviewed. Results In the 26 enrolled patients, 33 target lesions were identified, size ranging between 0.9 and 16.8 cm (mean 3 cm); 26 were LIRADS-5 or -M. CEUS identified 19 cases of residual tumor, 12 with no viable disease; while CT/MRI identified 17 cases of residual tumor, 16 with no viable disease (p = 0.617). Both CEUS and CT/MRI identified 5 portal vein thrombi, 2 lesions were missed or miscategorized on CEUS, while 6 were missed or miscategorized on CT/MRI (p = 0.289). Six new lesions were identified on both CEUS and CT/MRI ranging between 0.7 and 3.3 cm (mean 1.6 cm) on CEUS, and 0.7 and 2.8 cm (mean 1.7 cm) on CT/MRI. Of these new lesions, 4 were identified only on CT/MRI and 3 only by CEUS. Post-TACE, there was no significant difference in detecting residual tumor and no viable tumor between CEUS and CT/MRI (p = 0.617). Conclusion CEUS is non-inferior to CT/MRI performed at identical follow-up interval, in evaluating for residual versus treated HCC following first-time TACE. CEUS may represent an option for patients with contrast allergies or contraindications to MRI. CEUS can be used to examine small or isoechoic tumors after treatment.
McGillen et al. (Fri,) studied this question.