At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Diagnostic Performance of Deep Learning Image Reconstruction in Low Dose CT for the Detection of Acute Abdominal Conditions
In Brief
An observational study evaluating low-dose CT for Abdominal Pain and 4 related conditions. Completed, enrolled 246 participants across 2 sites in 2 countries.
Signals
Detailed Summary
The goal of this non-inferiority observational study is to assess the diagnostic performance of low-dose CT with deep learning image reconstruction (DLIR) in adult participants with acute abdominal conditions. The main research question is: • Can low-dose CT with DLIR achieve the same diagnostic performance as standard CT for the diagnosis of acute abdominal conditions. Participants will be examined with an additional low-dose CT directly after the standard CT. Participant will be their own controls. Registration record updated on 15.05.2026 to correct entry errors (correction of sample size calculation now resulting in a larger sample size than previously stated, mixed-effects logistic regression was used for analysis of the diagnostic accuracy) so that the record reflects the study protocol in effect before enrollment of the first participant.
Study Details
Timeline
Arms & Interventions
Participants under evaluation for an acute abdominal condition who are referred to CT of the abdomen and pelvis.
Interventions
Low-dose CT scan will be performed, not exceeding 30% radiation dose of the standard CT. Low-dose CT images will be reconstructed with TrueFidelity high. The low-dose CT will be performed directly after the standard CT to avoid bias from differences in the timing of the contrast phase.