Accuracy of Ultra-Low-Dose-CT of the Chest Compared to Plain Film in an Unfiltered Emergency Department Patient Cohort

NCT03922516 | Completed

• 1 other identifier: EK-Nr. 2254/2018
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chest Pain; Cough; Thoracic Diseases; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Sensitivity and Specificity of ULDCT and plain film

  1 year

• Frequency of change in radiological diagnosis

  1 year

• Frequency of change in emergency physician's diagnosis

  1 year

• Frequency of change in (planned) therapeutic course of action by emergency physician

  1 year

• Frequency of accidental diagnosis in ULDCT and plain film

  1 year

Study Arms (2)

Reporting order: Plain Film - ULDCT

OTHER

The plain film of half the participants (randomized) will be submitted for reporting by a radiologist as a first imaging method. After finishing this report, the same radiologist will assess the ULDCT of this participant. In this second report, the findings of both examinations will be summarized, and a second report will be filed. Emergency physicians will first receive the report for the plain film of the chest and will be asked for the diagnosis and its probability. Next, the report for ULDCT will be presented to them. Again, diagnosis and probabilities will be documented.

Diagnostic Test: ULDCT

Reporting order: ULDCT - Plain Film

OTHER

For half the participants (randomized) radiologists will first receive the data from ULDCT of the chest and write a report. Subsequently, they will receive the data from the plain film of the chest and may expand their report (explicitly separated). Emergency physicians will first receive the report for the ULDCT of the chest and will be asked for probabilities of the nine most frequent diagnoses in chest-imaging plus "other". Next, they will be presented with the report for the plain film and will again be asked to give an estimation of the probabilities for the same diagnoses as before.

Diagnostic Test: ULDCT

Interventions

ULDCT DIAGNOSTIC_TEST

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.

Reporting order: Plain Film - ULDCT; Reporting order: ULDCT - Plain Film

Eligibility Criteria

• Age: 18 Years - 92 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients who are assigned to a clinically indicated chest X-ray by the emergency department of Vienna General Hospital
• ability to provide informed consent
• informed consent after detailed patient briefing

You may not qualify if:

• the emergency departments assessment of a critical clinical condition oppose an examination with both modalities (ULDCT of the chest, chest X-ray)
• assigned to chest X-ray as follow-up
• women with positive ß-HCG-test

Sponsors & Collaborators

• Medical University of Vienna: lead
• Siemens AG: collaborator

Study Sites (1)

Vienna General Hospital - Medical University of Vienna

Vienna, 1090, Austria

Location

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Related Links

• Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection 2018a. Radiation Application in Medicine \| Health Portal \[Online\]. \[Accessed: 22 November 2018\].
• Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection 2018b. Radiation Exposure in Austria \| Health Portal \[Online\]. \[Accessed: 22 November
• German Federal Office for Radiation Protection. Diagnostic Reference Levels. June 2016
• Gesundheit Österreich GmbH (Health Austria GmbH). Update on diagnostic reference values for Austria 2017

MeSH Terms

Conditions

Chest Pain; Cough; Thoracic Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Officials

• Helmut Ringl, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: May 2, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)