Ultra-low-dose CT vs. chest X-ray in non-traumatic emergency department patients - a prospective randomised crossover cohort trial.

Background: Ultra-low-dose CT (ULDCT) examinations of the chest at only twice the radiation dose of a chest X-ray (CXR) now offer a valuable imaging alternative to CXR. This trial prospectively compares ULDCT and CXR for the detection rate of diagnoses and their clinical relevance in a low-prevalence cohort of non-traumatic emergency department patients. Methods: In this prospective crossover cohort trial, 294 non-traumatic emergency department patients with a clinically indicated CXR were included between May 2nd and November 26th of 2019 (www.clinicaltrials.gov: NCT03922516). All participants received both CXR and ULDCT, and were randomized into two arms with inverse reporting order. The detection rate of CXR was calculated from 'arm CXR' (n = 147; CXR first), and of ULDCT from 'arm ULDCT' (n = 147; ULDCT first). Additional information reported by the second exam in each arm was documented. From all available clinical and imaging data, expert radiologists and emergency physicians built a compound reference standard, including radiologically undetectable diagnoses, and assigned each finding to one of five clinical relevance categories for the respective patient. Findings: Detection rates for main diagnoses by CXR and ULDCT (mean effective dose: 0.22 mSv) were 9.1% (CI [5.2, 15.5]; 11/121) and 20.1% (CI [14.2, 27.7]; 27/134; Interpretation: In non-traumatic emergency department patients, ULDCT of the chest offered more than twice the detection rate for main diagnoses compared to CXR. Funding: The Department of Biomedical Imaging and Image-guided Therapy of Medical University of Vienna received funding from Siemens Healthineers (Erlangen, Germany) to employ two research assistants for one year.