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

Abstract

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. 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. Detection rates for main diagnoses by CXR and ULDCT (mean effective dose: 0.22mSv) were 9.1% (CI [5.2, 15.5]; 11/121) and 20.1% (CI [14.2, 27.7]; 27/134; P=0.016), respectively. As an additional imaging modality, ULDCT added 9.1% (CI [5.2, 15.5]; 11/121) of main diagnoses to prior CXRs, whereas CXRs did not add a single main diagnosis (0/134; P<0.001). Notably, ULDCT also offered higher detection rates than CXR for all other clinical relevance categories, including findings clinically irrelevant for the respective emergency department visit with 78.5% (CI [74.0, 82.5]; 278/354) vs. 16.2% (CI [12.7, 20.3]; 58/359) as a primary modality and 68.2% (CI [63.3, 72.8]; 245/359) vs. 2.5% (CI [1.3, 4.7]; 9/354) as an additional imaging modality. In non-traumatic emergency department patients, ULDCT of the chest offered more than twice the detection rate for main diagnoses compared to CXR. 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.