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OpenTrials
Completed

NCT Number: NCT04996693

On Dose Efficiency of Modern CT-scanners in Chest Scans

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.

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Key information

Conditions

Pneumonia Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Embolism Embolism and Thrombosis Heart Diseases Heart Valve Diseases Infections Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Disease Pulmonary Embolism Respiratory Tract Diseases Respiratory Tract Infections Respiratory Tract Neoplasms Thoracic Neoplasms Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Augsburg

Augsburg, Bavaria, 86156, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Imaging on Scanner with Spectral Imaging Capabilities

Diagnostic Test

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)

CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)

Diagnostic Test

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.

CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)

Diagnostic Test

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.

Primary outcomes

  1. Parameters of Objective Image Quality

    Time frame: 1 year

    Measured as signal, image noise and modulation transfer function equivalent parameters

  2. Parameters of Radiation Dose

    Time frame: 1 year

    measured as x-ray tube parameters such as dose length product (DLP)

Secondary outcomes

  1. Subjective Image Quality Evaluation (entire cohort and for individual disease groups)

    Time frame: 1 year

    measured by blinded evaluation by radiologists

Sponsors and collaborators

Lead sponsor

University Hospital Augsburg

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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