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NCT05651360

Diagnostic Performance of Low-Dose CT for Acute Abdominal Conditions

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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.

Official title: Diagnostic Performance of Deep Learning Image Reconstruction in Low Dose CT for the Detection of Acute Abdominal Conditions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

246

Start Date

2022-12-07

Completion Date

2023-07-10

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

low-dose CT

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.

Locations (2)

Odense University Hospital

Odense, Denmark

Oslo University Hospital

Oslo, Norway