On Dose Efficiency of Modern CT-scanners in Chest Scans

On Dose Efficiency of Modern CT-scanners in Chest Scans- a Prospective, Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Aortic Stenosis; Lung Cancer; Pulmonary Disease; Pulmonary Embolism
• Intervention / Treatment: Diagnostic test: Imaging on Scanner with Spectral Imaging Capabilities; 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)

• Study Type: Interventional
• Enrollment (Actual): 958
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • University Hospital Augsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Scanner 1; Imaging performed on scanner 1: Photon-Counting Detector CT	Diagnostic test: Imaging on Scanner with Spectral Imaging Capabilities; Patients will undergo imaging on a modern CT scanner with spectral imaging capabilities. A dose neutral spectral acquisition mode will routinely be used. Contrast material protocol and scan ranges are similar in all three arms.; Other Names: CT Scan using a Photon-Counting Detector CT: Naeotom Alpha (Siemens Healthineers)
Other: Scanner 2; Imaging performed on scanner 2: Energy-Integrating Detector CT (128-slice)	Diagnostic test: CT Scan using an Energy-Integrating Detector CT (128 slice MDCT); Patients will undergo imaging on a modern 128-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.
Other: Scanner 3; Imaging performed on scanner 3: Energy-Integrating Detector CT (20-slice)	Diagnostic test: CT Scan using an Energy-Integrating Detector CT (20-slice MDCT); Patients will undergo imaging on a modern 20-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Image Quality Evaluation (entire cohort and for individual disease groups)	measured by blinded evaluation by radiologists	1 year

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Investigators: Principal Investigator: Florian Schwarz, MD, Universitaetsklinikum Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Computed Tomography; Spectral CT; Dose efficiency
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Embolism; Aortic Valve Stenosis; Pulmonary Embolism
• Other Study ID Numbers: 21-0368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share individual participant data upon request (pending final approval by the data protection officer).
• IPD Sharing Time Frame: Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.
• IPD Sharing Access Criteria: We plan to share data on request at this point in time.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No