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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922516
Other study ID # EK-Nr. 2254/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2019
Est. completion date November 26, 2019

Study information

Verified date December 2019
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial compares the accuracy provided by plain film as well as ultra-low-dose-computed-tomography (ULDCT) of the chest. It also aims to analyze differences in diagnostic confidence and therapeutic consequence offered by these two imaging modalities.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ULDCT
Ultra-Low-Dose-CT (ULDCT) of the chest using tin filters with third-generation dual-energy CT devices. The projected dose used will be approximately 0.2 mSv per ULDCT of the chest.

Locations

Country Name City State
Austria Vienna General Hospital - Medical University of Vienna Vienna

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Vienna Siemens AG

Country where clinical trial is conducted

Austria, 

References & Publications (34)

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Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of ultra-low-dose-CT of the chest and plain film of the chest Initial radiologic diagnostic accuracy of both methods will be assessed by analyzing the number of reports that are changed after the images of the second modality become available to the radiologist in Arm 1 compared to Arm 2.
In a final approach, the diagnostic accuracy will be analyzed by retrospectively comparing all reports with the gold standard, which will be built from all available patient data at the end of the study, including all follow-up imaging studies and laboratory tests.
1 year
Secondary Sensitivity and Specificity of ULDCT and plain film Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
Secondary Frequency of change in radiological diagnosis Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
Secondary Frequency of change in emergency physician's diagnosis Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
Secondary Frequency of change in (planned) therapeutic course of action by emergency physician Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
Secondary Frequency of accidental diagnosis in ULDCT and plain film Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
Secondary Frequency of additional diagnostic imaging needed Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
Secondary Frequency of unclear reports in ULDCT and plain film Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
Secondary Diagnostic confidence in ULDCT and plain film by radiologist Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
Secondary Diagnostic confidence in ULDCT and plain film by emergency physician Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT" 1 year
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