On Dose Efficiency of Modern CT-scanners in Chest Scans

Not Applicable

Completed

• Conditions: Pulmonary Disease; Pneumonia; Pulmonary Embolism; Aortic Stenosis; Lung Cancer
• Interventions: Diagnostic Test: CT Scan using an Energy-Integrating Detector CT (128 slice MDCT); Diagnostic Test: CT Scan using an Energy-Integrating Detector CT (20-slice MDCT); Diagnostic Test: Imaging on Scanner with Spectral Imaging Capabilities

• Registration Number: NCT04996693
• Lead Sponsor: University Hospital Augsburg

Brief Summary

CT scans of the chest / thorax are of great importance both in the initial diagnosis and in the follow-up of pulmonary or thoracic diseases. As an example, CT angiography of the pulmonary arteries (CTPA) is worldwide considered to be gold standard test in patients with a suspicion for pulmonary embolism.

The aim of this study is to measure and compare dose efficiency of modern CT scanners for unenhanced and contrast-enhanced scan protocols of the chest/thorax. Patients who are referred for a CT of the chest/thorax will be randomly assigned to one of the three CT scanners currently in use at our institution.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-09
• Study Start: 2021-10-07
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 958

Inclusion Criteria

• patient is referred for an unenhanced CT OR contrast-enhanced CT of the chest/thorax confirmed by a board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
• patient is at least 18 years of age AND
• patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria

• high degree of medical urgency (i.e. patient cannot be consented for iv contrast according to routine procedures)
• known or suspected pregnancy, or lactating . contraindications for contrast agent (renal failure, allergy, hyperthyroidism)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scanner 2	CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)	Imaging performed on scanner 2: Energy-Integrating Detector CT (128-slice)
Scanner 3	CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)	Imaging performed on scanner 3: Energy-Integrating Detector CT (20-slice)
Scanner 1	Imaging on Scanner with Spectral Imaging Capabilities	Imaging performed on scanner 1: Photon-Counting Detector CT

Primary Outcome Measures

Name	Time	Method
Parameters of Objective Image Quality	1 year	Measured as signal, image noise and modulation transfer function equivalent parameters
Parameters of Radiation Dose	1 year	measured as x-ray tube parameters such as dose length product (DLP)

Secondary Outcome Measures

Name	Time	Method
Subjective Image Quality Evaluation (entire cohort and for individual disease groups)	1 year	measured by blinded evaluation by radiologists

Trial Locations

Locations (1)

University Hospital Augsburg; 🇩🇪 Augsburg, Bavaria, Germany