On Dose Efficiency of Modern CT-scanners in Chest Scans

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04996693
• Other study ID #: 21-0368
• Status: Completed
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2023
• Source: University Hospital Augsburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 958
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Embolism
• Lung Cancer
• Pneumonia
• Pulmonary Disease
• Pulmonary Embolism

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Augsburg	Augsburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters of Objective Image Quality	Measured as signal, image noise and modulation transfer function equivalent parameters	1 year
Primary	Parameters of Radiation Dose	measured as x-ray tube parameters such as dose length product (DLP)	1 year
Secondary	Subjective Image Quality Evaluation (entire cohort and for individual disease groups)	measured by blinded evaluation by radiologists	1 year